It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so. – Josh Billings
 

Some patients believe COVID-19 is a hoax. Many think there’s truth to the rumor that Bill Gates is behind it all and intends to use COVID vaccinations as a devious way to implant microchips in us. He will then, of course, use the new 5G towers to track us all (although what Gates will do with the information that I was shopping at a Trader Joe’s yesterday is yet unknown).

It’s easy to dismiss patients with these beliefs as nuts or dumb or both. They’re neither, they’re just human. Conspiracy theories have been shared from the first time two humans met. They are, after all, simply hypotheses to explain an experience that’s difficult to understand. Making up a story to explain things feels safer than living with the unknown, and so we do. Our natural tendency to be suspicious makes conspiracy hypotheses more salient and more likely to spread. The pandemic itself is exacerbating this problem: People are alone and afraid, and dependent on social media for connection. Add a compelling story about a nefarious robber baron plotting to exploit us and you’ve got the conditions for conspiracy theories to explode like wind-driven wildfires. Astonishingly, a Pew Research poll showed 36% of Americans surveyed who have heard something about it say the Bill Gates cabal theory is “probably” or “definitely” true.

That many patients fervently believe conspiracy theories poses several problems for us. First, when a vaccine does become available, some patients will refuse to be vaccinated. The consequences to their health and the health of the community are grave. Secondly, whenever patients have cause to distrust doctors, it makes our jobs more challenging. If they don’t trust us on vaccines, it can spread to not trusting us about wearing masks or sunscreens or taking statins. Lastly, it’s near impossible to have a friendly conversation with a patient carrying forth on why Bill Gates is not in jail or how I’m part of the medical-industrial complex enabling him. Sheesh.

It isn’t their fault. The underpinning of these beliefs can be understood as a cognitive bias. In this case, an idea that is easy to imagine or recall is believed to be true more than an idea that is complex and difficult. Understanding viral replication and R0 numbers or viral vectors and protein subunit vaccines is hard. Imagining a chip being injected into your arm is easy. And, as behavioral economist Daniel Kahneman opined, we humans possess an almost unlimited ability to ignore our ignorance. We physicians can help in a way that friends and family members can’t. Here are ways you can help patients who believe in conspiracy theories:

Approach this problem like any other infirmity, with compassion. No one wants to drink too much and knock out their teeth falling off a bike. It was a mistake. Similarly, when people are steeped in self-delusion, it’s not a misdeed, it’s a lapse. Be kind and respectful.

Meet them where they are. It might be helpful to state with sincerity: So you feel that there is a government plot to use COVID to track us? Have you considered that might not be true?

Have the conversation in private. Harder even than being wrong is being publicly wrong.

Try the Socratic method. (We’re pretty good at this from teaching students and residents.) Conspiracy-believing patients have the illusion of knowledge, yet, like students, it’s often easy to show them their gaps. Do so gently by leading them to discover for themselves.

Stop when you stall. You cannot change someone’s mind by dint of force. However, you surely can damage your relationship if you keep pushing them.

Don’t worry if you fail to break through; you might yet have moved them a bit. This might make it possible for them to discover the truth later. Or, you could simply switch to explain what holds up the ground we walk upon. There’s rumor we’re supported on the backs of turtles, all the way down. Maybe Bill Gates is feeding them.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so. – Josh Billings
 

Some patients believe COVID-19 is a hoax. Many think there’s truth to the rumor that Bill Gates is behind it all and intends to use COVID vaccinations as a devious way to implant microchips in us. He will then, of course, use the new 5G towers to track us all (although what Gates will do with the information that I was shopping at a Trader Joe’s yesterday is yet unknown).

It’s easy to dismiss patients with these beliefs as nuts or dumb or both. They’re neither, they’re just human. Conspiracy theories have been shared from the first time two humans met. They are, after all, simply hypotheses to explain an experience that’s difficult to understand. Making up a story to explain things feels safer than living with the unknown, and so we do. Our natural tendency to be suspicious makes conspiracy hypotheses more salient and more likely to spread. The pandemic itself is exacerbating this problem: People are alone and afraid, and dependent on social media for connection. Add a compelling story about a nefarious robber baron plotting to exploit us and you’ve got the conditions for conspiracy theories to explode like wind-driven wildfires. Astonishingly, a Pew Research poll showed 36% of Americans surveyed who have heard something about it say the Bill Gates cabal theory is “probably” or “definitely” true.

That many patients fervently believe conspiracy theories poses several problems for us. First, when a vaccine does become available, some patients will refuse to be vaccinated. The consequences to their health and the health of the community are grave. Secondly, whenever patients have cause to distrust doctors, it makes our jobs more challenging. If they don’t trust us on vaccines, it can spread to not trusting us about wearing masks or sunscreens or taking statins. Lastly, it’s near impossible to have a friendly conversation with a patient carrying forth on why Bill Gates is not in jail or how I’m part of the medical-industrial complex enabling him. Sheesh.

It isn’t their fault. The underpinning of these beliefs can be understood as a cognitive bias. In this case, an idea that is easy to imagine or recall is believed to be true more than an idea that is complex and difficult. Understanding viral replication and R0 numbers or viral vectors and protein subunit vaccines is hard. Imagining a chip being injected into your arm is easy. And, as behavioral economist Daniel Kahneman opined, we humans possess an almost unlimited ability to ignore our ignorance. We physicians can help in a way that friends and family members can’t. Here are ways you can help patients who believe in conspiracy theories:

Approach this problem like any other infirmity, with compassion. No one wants to drink too much and knock out their teeth falling off a bike. It was a mistake. Similarly, when people are steeped in self-delusion, it’s not a misdeed, it’s a lapse. Be kind and respectful.

Meet them where they are. It might be helpful to state with sincerity: So you feel that there is a government plot to use COVID to track us? Have you considered that might not be true?

Have the conversation in private. Harder even than being wrong is being publicly wrong.

Try the Socratic method. (We’re pretty good at this from teaching students and residents.) Conspiracy-believing patients have the illusion of knowledge, yet, like students, it’s often easy to show them their gaps. Do so gently by leading them to discover for themselves.

Stop when you stall. You cannot change someone’s mind by dint of force. However, you surely can damage your relationship if you keep pushing them.

Don’t worry if you fail to break through; you might yet have moved them a bit. This might make it possible for them to discover the truth later. Or, you could simply switch to explain what holds up the ground we walk upon. There’s rumor we’re supported on the backs of turtles, all the way down. Maybe Bill Gates is feeding them.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so. – Josh Billings
 

Some patients believe COVID-19 is a hoax. Many think there’s truth to the rumor that Bill Gates is behind it all and intends to use COVID vaccinations as a devious way to implant microchips in us. He will then, of course, use the new 5G towers to track us all (although what Gates will do with the information that I was shopping at a Trader Joe’s yesterday is yet unknown).

It’s easy to dismiss patients with these beliefs as nuts or dumb or both. They’re neither, they’re just human. Conspiracy theories have been shared from the first time two humans met. They are, after all, simply hypotheses to explain an experience that’s difficult to understand. Making up a story to explain things feels safer than living with the unknown, and so we do. Our natural tendency to be suspicious makes conspiracy hypotheses more salient and more likely to spread. The pandemic itself is exacerbating this problem: People are alone and afraid, and dependent on social media for connection. Add a compelling story about a nefarious robber baron plotting to exploit us and you’ve got the conditions for conspiracy theories to explode like wind-driven wildfires. Astonishingly, a Pew Research poll showed 36% of Americans surveyed who have heard something about it say the Bill Gates cabal theory is “probably” or “definitely” true.

That many patients fervently believe conspiracy theories poses several problems for us. First, when a vaccine does become available, some patients will refuse to be vaccinated. The consequences to their health and the health of the community are grave. Secondly, whenever patients have cause to distrust doctors, it makes our jobs more challenging. If they don’t trust us on vaccines, it can spread to not trusting us about wearing masks or sunscreens or taking statins. Lastly, it’s near impossible to have a friendly conversation with a patient carrying forth on why Bill Gates is not in jail or how I’m part of the medical-industrial complex enabling him. Sheesh.

It isn’t their fault. The underpinning of these beliefs can be understood as a cognitive bias. In this case, an idea that is easy to imagine or recall is believed to be true more than an idea that is complex and difficult. Understanding viral replication and R0 numbers or viral vectors and protein subunit vaccines is hard. Imagining a chip being injected into your arm is easy. And, as behavioral economist Daniel Kahneman opined, we humans possess an almost unlimited ability to ignore our ignorance. We physicians can help in a way that friends and family members can’t. Here are ways you can help patients who believe in conspiracy theories:

Approach this problem like any other infirmity, with compassion. No one wants to drink too much and knock out their teeth falling off a bike. It was a mistake. Similarly, when people are steeped in self-delusion, it’s not a misdeed, it’s a lapse. Be kind and respectful.

Meet them where they are. It might be helpful to state with sincerity: So you feel that there is a government plot to use COVID to track us? Have you considered that might not be true?

Have the conversation in private. Harder even than being wrong is being publicly wrong.

Try the Socratic method. (We’re pretty good at this from teaching students and residents.) Conspiracy-believing patients have the illusion of knowledge, yet, like students, it’s often easy to show them their gaps. Do so gently by leading them to discover for themselves.

Stop when you stall. You cannot change someone’s mind by dint of force. However, you surely can damage your relationship if you keep pushing them.

Don’t worry if you fail to break through; you might yet have moved them a bit. This might make it possible for them to discover the truth later. Or, you could simply switch to explain what holds up the ground we walk upon. There’s rumor we’re supported on the backs of turtles, all the way down. Maybe Bill Gates is feeding them.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

This patient was given a diagnosis of primary herpes simplex virus (HSV) based on the appearance of her eyelid. Swabs were performed for bacterial culture, and polymerase chain reaction (PCR) testing was done for HSV and varicella, but results were pending prior to her transfer to the Emergency Department (ED).

The patient was given a single dose of 800 mg oral acyclovir (200 mg/5mL) and 500 mg of oral cephalexin (250 mg/5mL) and referred to the ED for a more detailed eye exam and to exclude orbital erosions.

HSV classically causes clustered vesicles on an erythematous base. Superinfection with skin flora can cause pustules instead of vesicles. Severe complications of HSV can include widespread skin involvement, eczema herpeticum, local destruction, central nervous system involvement, throat infections (affecting airway and oral intake), and dissemination in immunocompromised hosts. Ocular or periorbital infections increase the risk of keratitis, corneal ulcers, and loss of sight. Viral involvement of the cornea is best seen with fluorescein staining.

In cases like this one, PCR is the preferred method of testing over viral cultures or serology, given its speed, accuracy, and temporal relevance. Ophthalmology referral is warranted, although it should not delay treatment. Topical and oral antivirals are both effective when treating corneal disease; patient preference should be considered.

Most cases of HSV may resolve without treatment; however, treatment started while vesicles are present and within 72 hours of infection may shorten the time of viral replication and prevent progression to stromal involvement.

After a 12-hour wait in the ED, this patient was seen by an ophthalmology resident who did not observe orbital erosions but did note umbilication and misdiagnosed molluscum contagiosum. Umbilication is not pathognomonic for molluscum; few experienced in diagnosing molluscum contagiosum would make this error.

The patient was instructed to stop the acyclovir. Two days later when the PCR came back positive for HSV-1 and the bacterial culture confirmed growth of superimposed Staphylococcus aureus, the patient had been lost to follow-up. A better approach would have been for the ophthalmology resident to continue the acyclovir until PCR excluded herpetic disease.

‌

Text courtesy of Tristan Reynolds, DO, Maine Dartmouth Family Medicine Residency, and Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

This patient was given a diagnosis of primary herpes simplex virus (HSV) based on the appearance of her eyelid. Swabs were performed for bacterial culture, and polymerase chain reaction (PCR) testing was done for HSV and varicella, but results were pending prior to her transfer to the Emergency Department (ED).

The patient was given a single dose of 800 mg oral acyclovir (200 mg/5mL) and 500 mg of oral cephalexin (250 mg/5mL) and referred to the ED for a more detailed eye exam and to exclude orbital erosions.

HSV classically causes clustered vesicles on an erythematous base. Superinfection with skin flora can cause pustules instead of vesicles. Severe complications of HSV can include widespread skin involvement, eczema herpeticum, local destruction, central nervous system involvement, throat infections (affecting airway and oral intake), and dissemination in immunocompromised hosts. Ocular or periorbital infections increase the risk of keratitis, corneal ulcers, and loss of sight. Viral involvement of the cornea is best seen with fluorescein staining.

In cases like this one, PCR is the preferred method of testing over viral cultures or serology, given its speed, accuracy, and temporal relevance. Ophthalmology referral is warranted, although it should not delay treatment. Topical and oral antivirals are both effective when treating corneal disease; patient preference should be considered.

Most cases of HSV may resolve without treatment; however, treatment started while vesicles are present and within 72 hours of infection may shorten the time of viral replication and prevent progression to stromal involvement.

After a 12-hour wait in the ED, this patient was seen by an ophthalmology resident who did not observe orbital erosions but did note umbilication and misdiagnosed molluscum contagiosum. Umbilication is not pathognomonic for molluscum; few experienced in diagnosing molluscum contagiosum would make this error.

The patient was instructed to stop the acyclovir. Two days later when the PCR came back positive for HSV-1 and the bacterial culture confirmed growth of superimposed Staphylococcus aureus, the patient had been lost to follow-up. A better approach would have been for the ophthalmology resident to continue the acyclovir until PCR excluded herpetic disease.

‌

Text courtesy of Tristan Reynolds, DO, Maine Dartmouth Family Medicine Residency, and Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

This patient was given a diagnosis of primary herpes simplex virus (HSV) based on the appearance of her eyelid. Swabs were performed for bacterial culture, and polymerase chain reaction (PCR) testing was done for HSV and varicella, but results were pending prior to her transfer to the Emergency Department (ED).

The patient was given a single dose of 800 mg oral acyclovir (200 mg/5mL) and 500 mg of oral cephalexin (250 mg/5mL) and referred to the ED for a more detailed eye exam and to exclude orbital erosions.

HSV classically causes clustered vesicles on an erythematous base. Superinfection with skin flora can cause pustules instead of vesicles. Severe complications of HSV can include widespread skin involvement, eczema herpeticum, local destruction, central nervous system involvement, throat infections (affecting airway and oral intake), and dissemination in immunocompromised hosts. Ocular or periorbital infections increase the risk of keratitis, corneal ulcers, and loss of sight. Viral involvement of the cornea is best seen with fluorescein staining.

In cases like this one, PCR is the preferred method of testing over viral cultures or serology, given its speed, accuracy, and temporal relevance. Ophthalmology referral is warranted, although it should not delay treatment. Topical and oral antivirals are both effective when treating corneal disease; patient preference should be considered.

Most cases of HSV may resolve without treatment; however, treatment started while vesicles are present and within 72 hours of infection may shorten the time of viral replication and prevent progression to stromal involvement.

After a 12-hour wait in the ED, this patient was seen by an ophthalmology resident who did not observe orbital erosions but did note umbilication and misdiagnosed molluscum contagiosum. Umbilication is not pathognomonic for molluscum; few experienced in diagnosing molluscum contagiosum would make this error.

The patient was instructed to stop the acyclovir. Two days later when the PCR came back positive for HSV-1 and the bacterial culture confirmed growth of superimposed Staphylococcus aureus, the patient had been lost to follow-up. A better approach would have been for the ophthalmology resident to continue the acyclovir until PCR excluded herpetic disease.

‌

Text courtesy of Tristan Reynolds, DO, Maine Dartmouth Family Medicine Residency, and Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

Early autumn is typically a quiet time for outpatient pediatricians. The school physicals are finished. The last-minute school physicals are finished. The “I forgot to get my child’s physical” physicals are finished. Respiratory syncytial virus and influenza seasons haven’t started. There is time for some self-reflection and sharpening the saw.

My reflective period each year tends to start with the unresolved “What do I want to be when I grow up?” Mind you, just because I’ve grown old doesn’t mean I’ve grown up. I never wanted to be a “grande personne” who, per Antoine de Saint-Exupéry in “Le Petit Prince,” will never understand why a minor item (Did the lamb eat the flower?) makes all the difference in the universe to a child. Awe and wonderment should remain a part of life. I enjoy reading that short story in the original French because, as my high school French vocabulary and conjugation have faded, any word I don’t recognize means exactly what my journey of a lifetime tells me it means, neither more nor less, just as Humpty Dumpty explained to Alice in Lewis Carroll’s “Through the Looking Glass.”

Along with my perennial favorites like “Le Petit Prince” and the Gettysburg Address, in this year’s folder for reflection are two essays I’ve collected this year. The first is a letter addressed from medical ethicist Ira Bedzow, PhD, to this year’s incoming class of medical students.

The essay gives advice to first-year medical students entering the profession of medicine. It talks about finding “something to say that you communicate with the whole and essence of your being.” There is lots of great counsel in the letter. It claims, “Only in a professional does one’s voice sing in harmony with one’s being. Want that for yourselves, for only a life undivided is a life of full integrity.”

I agree with the harmony part. I hesitate with the undivided part. A professional singer could be dedicated to opera but still sing in a barbershop quartet and a church choir, motivated by fun and fellowship. It is important to emphasize integrity and dedication to medical students. The letter does that well, but students must also develop a work-life balance. The ascetic life is not for everyone.

Life needs balance and moderation. I am pretty sure that Aristotle said that, but I never did spend much time studying the Classics. I use my periods of self-reflection to chart my life’s vector. I choose new skills to learn and challenges to meet. But as I grow older, I spend more time pruning those roles that no longer give me joy. Delayed gratification is an important character trait for success, but its value lessens as it becomes clear there are more days behind me than ahead.

The second essay reflects the views of Canon Brodar, a third-year medical student and divinity school graduate.

He attests to the willingness of medical trainees to accept their duties and personal risk during the crisis of the COVID-19 pandemic. He correctly points out the contributions his fellow students could make, but underestimates the negatives. During March 2020 when decisions were made to send third-year medical students home, the administrative focus was on the cost of their participation (consumption of scarce personal protective equipment) and the potential negative consequences (an additional person who might transmit the virus among patients.) Four months later, most medical students were back on the job.

Mr. Brodar’s eloquent description of duty and responsibility complement, and perhaps have evolved from, the integrity and dedication that Dr. Bedzow emphasized to incoming medical students. These are all character traits. These traits are not knowledge of anatomy or skill with a scalpel. They are attitudes that colleagues hope and expect to find in any person who puts on the white coat. With experience come two more key character traits – the moderation of a work-life balance and the judgment to weigh benefits, risks, and costs.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].

Early autumn is typically a quiet time for outpatient pediatricians. The school physicals are finished. The last-minute school physicals are finished. The “I forgot to get my child’s physical” physicals are finished. Respiratory syncytial virus and influenza seasons haven’t started. There is time for some self-reflection and sharpening the saw.

My reflective period each year tends to start with the unresolved “What do I want to be when I grow up?” Mind you, just because I’ve grown old doesn’t mean I’ve grown up. I never wanted to be a “grande personne” who, per Antoine de Saint-Exupéry in “Le Petit Prince,” will never understand why a minor item (Did the lamb eat the flower?) makes all the difference in the universe to a child. Awe and wonderment should remain a part of life. I enjoy reading that short story in the original French because, as my high school French vocabulary and conjugation have faded, any word I don’t recognize means exactly what my journey of a lifetime tells me it means, neither more nor less, just as Humpty Dumpty explained to Alice in Lewis Carroll’s “Through the Looking Glass.”

Along with my perennial favorites like “Le Petit Prince” and the Gettysburg Address, in this year’s folder for reflection are two essays I’ve collected this year. The first is a letter addressed from medical ethicist Ira Bedzow, PhD, to this year’s incoming class of medical students.

The essay gives advice to first-year medical students entering the profession of medicine. It talks about finding “something to say that you communicate with the whole and essence of your being.” There is lots of great counsel in the letter. It claims, “Only in a professional does one’s voice sing in harmony with one’s being. Want that for yourselves, for only a life undivided is a life of full integrity.”

I agree with the harmony part. I hesitate with the undivided part. A professional singer could be dedicated to opera but still sing in a barbershop quartet and a church choir, motivated by fun and fellowship. It is important to emphasize integrity and dedication to medical students. The letter does that well, but students must also develop a work-life balance. The ascetic life is not for everyone.

Life needs balance and moderation. I am pretty sure that Aristotle said that, but I never did spend much time studying the Classics. I use my periods of self-reflection to chart my life’s vector. I choose new skills to learn and challenges to meet. But as I grow older, I spend more time pruning those roles that no longer give me joy. Delayed gratification is an important character trait for success, but its value lessens as it becomes clear there are more days behind me than ahead.

The second essay reflects the views of Canon Brodar, a third-year medical student and divinity school graduate.

He attests to the willingness of medical trainees to accept their duties and personal risk during the crisis of the COVID-19 pandemic. He correctly points out the contributions his fellow students could make, but underestimates the negatives. During March 2020 when decisions were made to send third-year medical students home, the administrative focus was on the cost of their participation (consumption of scarce personal protective equipment) and the potential negative consequences (an additional person who might transmit the virus among patients.) Four months later, most medical students were back on the job.

Mr. Brodar’s eloquent description of duty and responsibility complement, and perhaps have evolved from, the integrity and dedication that Dr. Bedzow emphasized to incoming medical students. These are all character traits. These traits are not knowledge of anatomy or skill with a scalpel. They are attitudes that colleagues hope and expect to find in any person who puts on the white coat. With experience come two more key character traits – the moderation of a work-life balance and the judgment to weigh benefits, risks, and costs.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].

Early autumn is typically a quiet time for outpatient pediatricians. The school physicals are finished. The last-minute school physicals are finished. The “I forgot to get my child’s physical” physicals are finished. Respiratory syncytial virus and influenza seasons haven’t started. There is time for some self-reflection and sharpening the saw.

My reflective period each year tends to start with the unresolved “What do I want to be when I grow up?” Mind you, just because I’ve grown old doesn’t mean I’ve grown up. I never wanted to be a “grande personne” who, per Antoine de Saint-Exupéry in “Le Petit Prince,” will never understand why a minor item (Did the lamb eat the flower?) makes all the difference in the universe to a child. Awe and wonderment should remain a part of life. I enjoy reading that short story in the original French because, as my high school French vocabulary and conjugation have faded, any word I don’t recognize means exactly what my journey of a lifetime tells me it means, neither more nor less, just as Humpty Dumpty explained to Alice in Lewis Carroll’s “Through the Looking Glass.”

Along with my perennial favorites like “Le Petit Prince” and the Gettysburg Address, in this year’s folder for reflection are two essays I’ve collected this year. The first is a letter addressed from medical ethicist Ira Bedzow, PhD, to this year’s incoming class of medical students.

The essay gives advice to first-year medical students entering the profession of medicine. It talks about finding “something to say that you communicate with the whole and essence of your being.” There is lots of great counsel in the letter. It claims, “Only in a professional does one’s voice sing in harmony with one’s being. Want that for yourselves, for only a life undivided is a life of full integrity.”

I agree with the harmony part. I hesitate with the undivided part. A professional singer could be dedicated to opera but still sing in a barbershop quartet and a church choir, motivated by fun and fellowship. It is important to emphasize integrity and dedication to medical students. The letter does that well, but students must also develop a work-life balance. The ascetic life is not for everyone.

Life needs balance and moderation. I am pretty sure that Aristotle said that, but I never did spend much time studying the Classics. I use my periods of self-reflection to chart my life’s vector. I choose new skills to learn and challenges to meet. But as I grow older, I spend more time pruning those roles that no longer give me joy. Delayed gratification is an important character trait for success, but its value lessens as it becomes clear there are more days behind me than ahead.

The second essay reflects the views of Canon Brodar, a third-year medical student and divinity school graduate.

He attests to the willingness of medical trainees to accept their duties and personal risk during the crisis of the COVID-19 pandemic. He correctly points out the contributions his fellow students could make, but underestimates the negatives. During March 2020 when decisions were made to send third-year medical students home, the administrative focus was on the cost of their participation (consumption of scarce personal protective equipment) and the potential negative consequences (an additional person who might transmit the virus among patients.) Four months later, most medical students were back on the job.

Mr. Brodar’s eloquent description of duty and responsibility complement, and perhaps have evolved from, the integrity and dedication that Dr. Bedzow emphasized to incoming medical students. These are all character traits. These traits are not knowledge of anatomy or skill with a scalpel. They are attitudes that colleagues hope and expect to find in any person who puts on the white coat. With experience come two more key character traits – the moderation of a work-life balance and the judgment to weigh benefits, risks, and costs.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].

Although COVID-19 has had negative effects on cancer research, the pandemic has also led to democratization of clinical trials, according to a panelist who spoke at the AACR virtual meeting: COVID-19 and Cancer.

The pandemic has taught researchers how to decentralize trials, which should not only improve patient satisfaction but increase trial accrual by providing access to typically underserved populations, Patricia M. LoRusso, DO, of Yale University, New Haven, Conn., said at the meeting.

Dr. LoRusso was one of six panelists who participated in a forum about changes to cancer trials that were prompted by the pandemic. The forum was moderated by Keith T. Flaherty, MD, of Massachusetts General Hospital in Boston.

Dr. Flaherty asked the panelists to explain adjustments their organizations have made in response to the pandemic, discuss accomplishments, and speculate on future challenges and priorities.
 

Trial, administrative, and patient-care modifications

COVID-19 put some cancer trials on hold. For others, the pandemic forced sponsors and study chairs to reduce trial complexity and identify nonessential aspects of the studies, according to panelist José Baselga, MD, PhD, of AstraZeneca.

Specifically, exploratory objectives were subjugated to patient safety and a focus on the primary endpoints of each trial.

Once the critical data were identified, study chairs were asked to determine whether data could be obtained through technologies that could substitute for face-to-face contact between patients and staff – for example, patient-reported outcome tools and at-home digital monitoring.

Modifications prompted by the pandemic include the following:

• On-site auditing was suspended.
• Oral investigational agents were shipped directly to patients.
• “Remote” informed consent (telephone or video consenting) was permitted.
• Local providers could perform study-related services, with oversight by the research site.
• Minor deviations from the written protocols were allowed, provided the deviations did not affect patient care or data integrity.

“Obviously, the pandemic has been horrible, but what it has allowed us to do, as investigators in the clinical research landscape, … is to change our focus somewhat and realize, first and foremost, the patient is at the center of this,” Dr. LoRusso said.
 

Operational accomplishments and benefits

The pandemic caused a 40% decline in accrual to studies supported by the National Cancer Institute’s (NCI) Clinical Trials Network (NCTN) from mid-March to early April, according to James H. Doroshow, MD, of NCI.

However, after modifications to administrative and regulatory procedures, accrual to NCTN trials recovered to approximately 80% of prepandemic levels, Dr. Doroshow said.

The pandemic prompted investigators to leverage tools and technology they had not previously used frequently or at all, the panelists pointed out.

Investigators discovered perforce that telehealth could be used for almost all trial-related assessments. In lieu of physical examination, patients could send pictures of rashes and use electronic devices to monitor blood sugar values and vital signs.

Digital radiographic studies were performed at sites that were most convenient for patients, downloaded, and reinterpreted at the study institution. Visiting nurses and neighborhood laboratories enabled less-frequent in-person visits for assessments.

These adjustments have been particularly important for geographically and/or socioeconomically disadvantaged patients, the panelists said.

Overall, there was agreement among the panelists that shared values and trust among regulatory authorities, sponsors, investigators, and clinicians were impressive in their urgency, sincerity, and patient centricity.

“This pandemic … has forced us to think differently and be nimble and creative to our approach to maintaining our overriding goals while at the same time bringing these innovative therapies forward for patients with cancer and other serious and life-threatening diseases as quickly as possible,” said panelist Kristen M. Hege, MD, of Bristol-Myers Squibb.

In fact, Dr. Hege noted, some cancer-related therapies (e.g., BTK inhibitors, JAK inhibitors, and immunomodulatory agents) were “repurposed” rapidly and tested against COVID-related complications.
 

Streamlining trial regulatory processes

In addition to changing ongoing trials, the pandemic has affected how new research projects are launched.

One new study that came together quickly in response to the pandemic is the NCI COVID-19 in Cancer Patients Study (NCCAPS). NCCAPS is a natural history study with biospecimens and an imaging library. It was approved in just 5 weeks and is active in 650 sites, with “gangbusters” accrual, Dr. Doroshow said.

The rapidness of NCCAPS’ design and implementation should prompt the revision of previously accepted timelines for trial activation and lead to streamlined future processes.

Another project that was launched quickly in response to the pandemic is the COVID-19 evidence accelerator, according to Paul G. Kluetz, MD, of the Food and Drug Administration.

The COVID-19 evidence accelerator integrates real-world evidence into a database to provide investigators and health systems with the ability to gather information, design rapid turnaround queries, and share results. The evidence accelerator can provide study chairs with information that may have relevance to the safety of participants in clinical trials.
 

Future directions and challenges

The panelists agreed that pandemic-related modifications in processes will not only accelerate trial approval and activation but should facilitate higher study accrual, increase the diversity of protocol participants, and decrease the costs associated with clinical trial conduct.

With that in mind, the NCI is planning randomized clinical trials in which “process A” is compared with “process B,” Dr. Doroshow said. The goal is to determine which modifications are most likely to make trials available to patients without compromising data integrity or patient safety.

“How much less data do you need to have an outcome that will be similar?” Dr. Doroshow asked. “How many fewer visits, how many fewer tests, how much can you save? Physicians, clinical trialists, all of us respond to data, and if you get the same outcome at a third of the cost, then everybody benefits.”

Nonetheless, we will need to be vigilant for unintended vulnerabilities from well-intended efforts, according to Dr. Kluetz. Study chairs, sponsors, and regulatory agencies will need to be attentive to whether there are important differences in scan quality or interpretation, missing data that influence trial outcomes, and so on.

Dr. Hege pointed out that differences among data sources may be less important when treatments generate large effects but may be vitally important when the relative differences among treatments are small.

On a practical level, decentralizing clinical research may negatively impact the finances of tertiary care centers, which could threaten the required infrastructure for clinical trials, a few panelists noted.

The relative balance of NCI-, industry-, and investigator-initiated trials may require adjustment so that research income is adequate to maintain the costs associated with cancer clinical trials.
 

Shared goals and democratization

The pandemic has required all stakeholders in clinical research to rely on relationships of trust and shared goals, said Caroline Robert, MD, PhD, of Institut Gustave Roussy in Villejuif, France.

Dr. Kluetz summarized those goals as improving trial efficiencies, decreasing patient burden, decentralizing trials, and maintaining trial integrity.

A decentralized clinical trials operational model could lead to better generalizability of study outcomes, normalization of life for patients on studies, and lower costs of trial conduct. As such, decentralization would promote democratization.

Coupled with ongoing efforts to reduce eligibility criteria in cancer trials, the pandemic has brought operational solutions that should be perpetuated and has reminded us of the interlocking and mutually supportive relationships on which clinical research success depends.

Dr. Doroshow and Dr. Kluetz disclosed no conflicts of interest. All other panelists disclosed financial relationships, including employment, with a range of companies.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Flaherty KT et al. AACR: COVID-19 and Cancer, Regulatory and Operational Implications of Cancer Clinical Trial Changes During COVID-19.

Although COVID-19 has had negative effects on cancer research, the pandemic has also led to democratization of clinical trials, according to a panelist who spoke at the AACR virtual meeting: COVID-19 and Cancer.

The pandemic has taught researchers how to decentralize trials, which should not only improve patient satisfaction but increase trial accrual by providing access to typically underserved populations, Patricia M. LoRusso, DO, of Yale University, New Haven, Conn., said at the meeting.

Dr. LoRusso was one of six panelists who participated in a forum about changes to cancer trials that were prompted by the pandemic. The forum was moderated by Keith T. Flaherty, MD, of Massachusetts General Hospital in Boston.

Dr. Flaherty asked the panelists to explain adjustments their organizations have made in response to the pandemic, discuss accomplishments, and speculate on future challenges and priorities.
 

Trial, administrative, and patient-care modifications

COVID-19 put some cancer trials on hold. For others, the pandemic forced sponsors and study chairs to reduce trial complexity and identify nonessential aspects of the studies, according to panelist José Baselga, MD, PhD, of AstraZeneca.

Specifically, exploratory objectives were subjugated to patient safety and a focus on the primary endpoints of each trial.

Once the critical data were identified, study chairs were asked to determine whether data could be obtained through technologies that could substitute for face-to-face contact between patients and staff – for example, patient-reported outcome tools and at-home digital monitoring.

Modifications prompted by the pandemic include the following:

• On-site auditing was suspended.
• Oral investigational agents were shipped directly to patients.
• “Remote” informed consent (telephone or video consenting) was permitted.
• Local providers could perform study-related services, with oversight by the research site.
• Minor deviations from the written protocols were allowed, provided the deviations did not affect patient care or data integrity.

“Obviously, the pandemic has been horrible, but what it has allowed us to do, as investigators in the clinical research landscape, … is to change our focus somewhat and realize, first and foremost, the patient is at the center of this,” Dr. LoRusso said.
 

Operational accomplishments and benefits

The pandemic caused a 40% decline in accrual to studies supported by the National Cancer Institute’s (NCI) Clinical Trials Network (NCTN) from mid-March to early April, according to James H. Doroshow, MD, of NCI.

However, after modifications to administrative and regulatory procedures, accrual to NCTN trials recovered to approximately 80% of prepandemic levels, Dr. Doroshow said.

The pandemic prompted investigators to leverage tools and technology they had not previously used frequently or at all, the panelists pointed out.

Investigators discovered perforce that telehealth could be used for almost all trial-related assessments. In lieu of physical examination, patients could send pictures of rashes and use electronic devices to monitor blood sugar values and vital signs.

Digital radiographic studies were performed at sites that were most convenient for patients, downloaded, and reinterpreted at the study institution. Visiting nurses and neighborhood laboratories enabled less-frequent in-person visits for assessments.

These adjustments have been particularly important for geographically and/or socioeconomically disadvantaged patients, the panelists said.

Overall, there was agreement among the panelists that shared values and trust among regulatory authorities, sponsors, investigators, and clinicians were impressive in their urgency, sincerity, and patient centricity.

“This pandemic … has forced us to think differently and be nimble and creative to our approach to maintaining our overriding goals while at the same time bringing these innovative therapies forward for patients with cancer and other serious and life-threatening diseases as quickly as possible,” said panelist Kristen M. Hege, MD, of Bristol-Myers Squibb.

In fact, Dr. Hege noted, some cancer-related therapies (e.g., BTK inhibitors, JAK inhibitors, and immunomodulatory agents) were “repurposed” rapidly and tested against COVID-related complications.
 

Streamlining trial regulatory processes

In addition to changing ongoing trials, the pandemic has affected how new research projects are launched.

One new study that came together quickly in response to the pandemic is the NCI COVID-19 in Cancer Patients Study (NCCAPS). NCCAPS is a natural history study with biospecimens and an imaging library. It was approved in just 5 weeks and is active in 650 sites, with “gangbusters” accrual, Dr. Doroshow said.

The rapidness of NCCAPS’ design and implementation should prompt the revision of previously accepted timelines for trial activation and lead to streamlined future processes.

Another project that was launched quickly in response to the pandemic is the COVID-19 evidence accelerator, according to Paul G. Kluetz, MD, of the Food and Drug Administration.

The COVID-19 evidence accelerator integrates real-world evidence into a database to provide investigators and health systems with the ability to gather information, design rapid turnaround queries, and share results. The evidence accelerator can provide study chairs with information that may have relevance to the safety of participants in clinical trials.
 

Future directions and challenges

The panelists agreed that pandemic-related modifications in processes will not only accelerate trial approval and activation but should facilitate higher study accrual, increase the diversity of protocol participants, and decrease the costs associated with clinical trial conduct.

With that in mind, the NCI is planning randomized clinical trials in which “process A” is compared with “process B,” Dr. Doroshow said. The goal is to determine which modifications are most likely to make trials available to patients without compromising data integrity or patient safety.

“How much less data do you need to have an outcome that will be similar?” Dr. Doroshow asked. “How many fewer visits, how many fewer tests, how much can you save? Physicians, clinical trialists, all of us respond to data, and if you get the same outcome at a third of the cost, then everybody benefits.”

Nonetheless, we will need to be vigilant for unintended vulnerabilities from well-intended efforts, according to Dr. Kluetz. Study chairs, sponsors, and regulatory agencies will need to be attentive to whether there are important differences in scan quality or interpretation, missing data that influence trial outcomes, and so on.

Dr. Hege pointed out that differences among data sources may be less important when treatments generate large effects but may be vitally important when the relative differences among treatments are small.

On a practical level, decentralizing clinical research may negatively impact the finances of tertiary care centers, which could threaten the required infrastructure for clinical trials, a few panelists noted.

The relative balance of NCI-, industry-, and investigator-initiated trials may require adjustment so that research income is adequate to maintain the costs associated with cancer clinical trials.
 

Shared goals and democratization

The pandemic has required all stakeholders in clinical research to rely on relationships of trust and shared goals, said Caroline Robert, MD, PhD, of Institut Gustave Roussy in Villejuif, France.

Dr. Kluetz summarized those goals as improving trial efficiencies, decreasing patient burden, decentralizing trials, and maintaining trial integrity.

A decentralized clinical trials operational model could lead to better generalizability of study outcomes, normalization of life for patients on studies, and lower costs of trial conduct. As such, decentralization would promote democratization.

Coupled with ongoing efforts to reduce eligibility criteria in cancer trials, the pandemic has brought operational solutions that should be perpetuated and has reminded us of the interlocking and mutually supportive relationships on which clinical research success depends.

Dr. Doroshow and Dr. Kluetz disclosed no conflicts of interest. All other panelists disclosed financial relationships, including employment, with a range of companies.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Flaherty KT et al. AACR: COVID-19 and Cancer, Regulatory and Operational Implications of Cancer Clinical Trial Changes During COVID-19.

Although COVID-19 has had negative effects on cancer research, the pandemic has also led to democratization of clinical trials, according to a panelist who spoke at the AACR virtual meeting: COVID-19 and Cancer.

The pandemic has taught researchers how to decentralize trials, which should not only improve patient satisfaction but increase trial accrual by providing access to typically underserved populations, Patricia M. LoRusso, DO, of Yale University, New Haven, Conn., said at the meeting.

Dr. LoRusso was one of six panelists who participated in a forum about changes to cancer trials that were prompted by the pandemic. The forum was moderated by Keith T. Flaherty, MD, of Massachusetts General Hospital in Boston.

Dr. Flaherty asked the panelists to explain adjustments their organizations have made in response to the pandemic, discuss accomplishments, and speculate on future challenges and priorities.
 

Trial, administrative, and patient-care modifications

COVID-19 put some cancer trials on hold. For others, the pandemic forced sponsors and study chairs to reduce trial complexity and identify nonessential aspects of the studies, according to panelist José Baselga, MD, PhD, of AstraZeneca.

Specifically, exploratory objectives were subjugated to patient safety and a focus on the primary endpoints of each trial.

Once the critical data were identified, study chairs were asked to determine whether data could be obtained through technologies that could substitute for face-to-face contact between patients and staff – for example, patient-reported outcome tools and at-home digital monitoring.

Modifications prompted by the pandemic include the following:

• On-site auditing was suspended.
• Oral investigational agents were shipped directly to patients.
• “Remote” informed consent (telephone or video consenting) was permitted.
• Local providers could perform study-related services, with oversight by the research site.
• Minor deviations from the written protocols were allowed, provided the deviations did not affect patient care or data integrity.

“Obviously, the pandemic has been horrible, but what it has allowed us to do, as investigators in the clinical research landscape, … is to change our focus somewhat and realize, first and foremost, the patient is at the center of this,” Dr. LoRusso said.
 

Operational accomplishments and benefits

The pandemic caused a 40% decline in accrual to studies supported by the National Cancer Institute’s (NCI) Clinical Trials Network (NCTN) from mid-March to early April, according to James H. Doroshow, MD, of NCI.

However, after modifications to administrative and regulatory procedures, accrual to NCTN trials recovered to approximately 80% of prepandemic levels, Dr. Doroshow said.

The pandemic prompted investigators to leverage tools and technology they had not previously used frequently or at all, the panelists pointed out.

Investigators discovered perforce that telehealth could be used for almost all trial-related assessments. In lieu of physical examination, patients could send pictures of rashes and use electronic devices to monitor blood sugar values and vital signs.

Digital radiographic studies were performed at sites that were most convenient for patients, downloaded, and reinterpreted at the study institution. Visiting nurses and neighborhood laboratories enabled less-frequent in-person visits for assessments.

These adjustments have been particularly important for geographically and/or socioeconomically disadvantaged patients, the panelists said.

Overall, there was agreement among the panelists that shared values and trust among regulatory authorities, sponsors, investigators, and clinicians were impressive in their urgency, sincerity, and patient centricity.

“This pandemic … has forced us to think differently and be nimble and creative to our approach to maintaining our overriding goals while at the same time bringing these innovative therapies forward for patients with cancer and other serious and life-threatening diseases as quickly as possible,” said panelist Kristen M. Hege, MD, of Bristol-Myers Squibb.

In fact, Dr. Hege noted, some cancer-related therapies (e.g., BTK inhibitors, JAK inhibitors, and immunomodulatory agents) were “repurposed” rapidly and tested against COVID-related complications.
 

Streamlining trial regulatory processes

In addition to changing ongoing trials, the pandemic has affected how new research projects are launched.

One new study that came together quickly in response to the pandemic is the NCI COVID-19 in Cancer Patients Study (NCCAPS). NCCAPS is a natural history study with biospecimens and an imaging library. It was approved in just 5 weeks and is active in 650 sites, with “gangbusters” accrual, Dr. Doroshow said.

The rapidness of NCCAPS’ design and implementation should prompt the revision of previously accepted timelines for trial activation and lead to streamlined future processes.

Another project that was launched quickly in response to the pandemic is the COVID-19 evidence accelerator, according to Paul G. Kluetz, MD, of the Food and Drug Administration.

The COVID-19 evidence accelerator integrates real-world evidence into a database to provide investigators and health systems with the ability to gather information, design rapid turnaround queries, and share results. The evidence accelerator can provide study chairs with information that may have relevance to the safety of participants in clinical trials.
 

Future directions and challenges

The panelists agreed that pandemic-related modifications in processes will not only accelerate trial approval and activation but should facilitate higher study accrual, increase the diversity of protocol participants, and decrease the costs associated with clinical trial conduct.

With that in mind, the NCI is planning randomized clinical trials in which “process A” is compared with “process B,” Dr. Doroshow said. The goal is to determine which modifications are most likely to make trials available to patients without compromising data integrity or patient safety.

“How much less data do you need to have an outcome that will be similar?” Dr. Doroshow asked. “How many fewer visits, how many fewer tests, how much can you save? Physicians, clinical trialists, all of us respond to data, and if you get the same outcome at a third of the cost, then everybody benefits.”

Nonetheless, we will need to be vigilant for unintended vulnerabilities from well-intended efforts, according to Dr. Kluetz. Study chairs, sponsors, and regulatory agencies will need to be attentive to whether there are important differences in scan quality or interpretation, missing data that influence trial outcomes, and so on.

Dr. Hege pointed out that differences among data sources may be less important when treatments generate large effects but may be vitally important when the relative differences among treatments are small.

On a practical level, decentralizing clinical research may negatively impact the finances of tertiary care centers, which could threaten the required infrastructure for clinical trials, a few panelists noted.

The relative balance of NCI-, industry-, and investigator-initiated trials may require adjustment so that research income is adequate to maintain the costs associated with cancer clinical trials.
 

Shared goals and democratization

The pandemic has required all stakeholders in clinical research to rely on relationships of trust and shared goals, said Caroline Robert, MD, PhD, of Institut Gustave Roussy in Villejuif, France.

Dr. Kluetz summarized those goals as improving trial efficiencies, decreasing patient burden, decentralizing trials, and maintaining trial integrity.

A decentralized clinical trials operational model could lead to better generalizability of study outcomes, normalization of life for patients on studies, and lower costs of trial conduct. As such, decentralization would promote democratization.

Coupled with ongoing efforts to reduce eligibility criteria in cancer trials, the pandemic has brought operational solutions that should be perpetuated and has reminded us of the interlocking and mutually supportive relationships on which clinical research success depends.

Dr. Doroshow and Dr. Kluetz disclosed no conflicts of interest. All other panelists disclosed financial relationships, including employment, with a range of companies.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Flaherty KT et al. AACR: COVID-19 and Cancer, Regulatory and Operational Implications of Cancer Clinical Trial Changes During COVID-19.

Baseline gene expression in patients with chronic myeloid leukemia (CML) who received tyrosine kinase inhibitor (TKI) therapy in the phase 3 ENESTnd trial differentiated those who achieved a good response from those with a poor response at 5 years in an exploratory analysis.

The investigators developed gene-expression models based on RNA sequencing of whole blood samples collected prior to treatment with nilotinib or imatinib in study participants who completed at least 5 years of therapy, including both good responders – those who achieved a major molecular response (MMR), defined as BCR-ABL1IS (a gene sequence found in an abnormal chromosome 22) less than 0.01% by 12 months and sustained deep molecular response (DMR) by 5 years, and poor responders – those without MMR by 12 months or with BCR-ABL1IS greater than 10% at 3 months.

A model based on the comparison of gene signatures from 47 patients who achieved a molecular response of 4.5 (MR^4.5) on the International Scale (BCR-ABL1S less than 0.00032%), compared with 23 patients with a poor response, best predicted 5-year responder status (area under the receiver operating characteristic curve, 0.76), Jerald P. Radich, MD, reported during the Society of Hematologic Oncology virtual meeting.

“For this kind of work, that’s really quite good,” said Dr. Radich of the clinical research division at Fred Hutchinson Cancer Research Center, Seattle.

Notably, the differences in patient responses observed by 12 months in ENESTnd persisted for up to 10 years, he said.

The findings have potential implications for drug development and facilitation of DMR in patients on TKI therapy – a prerequisite for attempting treatment-free remission, he said.

Dr. Radich and colleagues assessed 24 clinical factors – such as Sokal risk score, TKI therapy type, age, and sex – according to responder status, and applied penalized regression to the clinical variables, to expression of 13,575 genes, and to a combination of the clinical variables and gene expression.

Clinical variables didn’t predict response in the trial, and including the clinical variables in the gene-expression model in the exploratory analysis did not improve it’s performance (AUC, 0.75). However, both the MR^4.5 plus clinical variables model and the MR^4.5-only model outperformed the clinical variables–only model (AUC, 0.59), he noted, adding: “So gene expression seems to be highly correlated with response.”

Of note, 458 genes were differentially expressed; those found in responders were most often associated with immune response, whereas those in poor responders were more likely to be associated with drug catabolism, WNT signaling, and cell cycle.

This suggests that good responders, compared with poor responders, have an activated immune system that is better able to engage after TKI therapy is administered to “cull through the heard, so to speak,” Dr. Radich said.

The findings were validated in an independent dataset of 19 good responders and 25 poor responders (AUC, 0.67 for the MR4.5 vs. poor-responder model).

A comparison of the expression of immune cell marker genes in good responders and poor responders further showed that T cells – particularly CD8 T cells, B cells, natural killer cells, and aggregate cytotoxic lymphocytes were expressed at significantly higher levels in good responders.

This was true in both the ENESTnd cohort and the validation dataset, he said.

The ENESTnd study is a randomized, open-label study comparing nilotinib and imatinib in adults with newly diagnosed Philadelphia chromosome–positive chronic-phase CML. A 5-year study update published in 2016 showed that 54% and 52% of patients in nilotinib 300- and 400-mg twice-daily arms, respectively, achieved MR^4.5, compared with 31% of those in an imatinib 400-mg once-daily arm. In the current exploratory analysis, the gene expression model differentiated between good and poor responders regardless of the TKI used, Dr. Radich said.

The findings are of note because achieving sustained deep molecular response is necessary before CML patients can attempt treatment-free remission and because biomarkers for predicting DMR have been lacking, he explained.

“These findings could really be used, potentially, for a couple of things: One is to predict response, and that could drive patient goals, expectations, and maybe drug choice,” he said.

The findings could also be used to inform clinical trials to investigate how to best treat poor responders to improve their response, he added.

“I think there’s a lot of work to be done and a lot things to chew over, and we’re hoping that we’ll have more to talk to you about in the future,” he said.

The study was sponsored by Novartis. Dr. Radich is a paid consultant for Genentech, Cepheid, Bristol-Myers Squibb, Takeda, and Novartis.

[email protected]

SOURCE: Radich JP et al. SOHO 2020, Abstract CML-109.

Baseline gene expression in patients with chronic myeloid leukemia (CML) who received tyrosine kinase inhibitor (TKI) therapy in the phase 3 ENESTnd trial differentiated those who achieved a good response from those with a poor response at 5 years in an exploratory analysis.

The investigators developed gene-expression models based on RNA sequencing of whole blood samples collected prior to treatment with nilotinib or imatinib in study participants who completed at least 5 years of therapy, including both good responders – those who achieved a major molecular response (MMR), defined as BCR-ABL1IS (a gene sequence found in an abnormal chromosome 22) less than 0.01% by 12 months and sustained deep molecular response (DMR) by 5 years, and poor responders – those without MMR by 12 months or with BCR-ABL1IS greater than 10% at 3 months.

A model based on the comparison of gene signatures from 47 patients who achieved a molecular response of 4.5 (MR^4.5) on the International Scale (BCR-ABL1S less than 0.00032%), compared with 23 patients with a poor response, best predicted 5-year responder status (area under the receiver operating characteristic curve, 0.76), Jerald P. Radich, MD, reported during the Society of Hematologic Oncology virtual meeting.

“For this kind of work, that’s really quite good,” said Dr. Radich of the clinical research division at Fred Hutchinson Cancer Research Center, Seattle.

Notably, the differences in patient responses observed by 12 months in ENESTnd persisted for up to 10 years, he said.

The findings have potential implications for drug development and facilitation of DMR in patients on TKI therapy – a prerequisite for attempting treatment-free remission, he said.

Dr. Radich and colleagues assessed 24 clinical factors – such as Sokal risk score, TKI therapy type, age, and sex – according to responder status, and applied penalized regression to the clinical variables, to expression of 13,575 genes, and to a combination of the clinical variables and gene expression.

Clinical variables didn’t predict response in the trial, and including the clinical variables in the gene-expression model in the exploratory analysis did not improve it’s performance (AUC, 0.75). However, both the MR^4.5 plus clinical variables model and the MR^4.5-only model outperformed the clinical variables–only model (AUC, 0.59), he noted, adding: “So gene expression seems to be highly correlated with response.”

Of note, 458 genes were differentially expressed; those found in responders were most often associated with immune response, whereas those in poor responders were more likely to be associated with drug catabolism, WNT signaling, and cell cycle.

This suggests that good responders, compared with poor responders, have an activated immune system that is better able to engage after TKI therapy is administered to “cull through the heard, so to speak,” Dr. Radich said.

The findings were validated in an independent dataset of 19 good responders and 25 poor responders (AUC, 0.67 for the MR4.5 vs. poor-responder model).

A comparison of the expression of immune cell marker genes in good responders and poor responders further showed that T cells – particularly CD8 T cells, B cells, natural killer cells, and aggregate cytotoxic lymphocytes were expressed at significantly higher levels in good responders.

This was true in both the ENESTnd cohort and the validation dataset, he said.

The ENESTnd study is a randomized, open-label study comparing nilotinib and imatinib in adults with newly diagnosed Philadelphia chromosome–positive chronic-phase CML. A 5-year study update published in 2016 showed that 54% and 52% of patients in nilotinib 300- and 400-mg twice-daily arms, respectively, achieved MR^4.5, compared with 31% of those in an imatinib 400-mg once-daily arm. In the current exploratory analysis, the gene expression model differentiated between good and poor responders regardless of the TKI used, Dr. Radich said.

The findings are of note because achieving sustained deep molecular response is necessary before CML patients can attempt treatment-free remission and because biomarkers for predicting DMR have been lacking, he explained.

“These findings could really be used, potentially, for a couple of things: One is to predict response, and that could drive patient goals, expectations, and maybe drug choice,” he said.

The findings could also be used to inform clinical trials to investigate how to best treat poor responders to improve their response, he added.

“I think there’s a lot of work to be done and a lot things to chew over, and we’re hoping that we’ll have more to talk to you about in the future,” he said.

The study was sponsored by Novartis. Dr. Radich is a paid consultant for Genentech, Cepheid, Bristol-Myers Squibb, Takeda, and Novartis.

[email protected]

SOURCE: Radich JP et al. SOHO 2020, Abstract CML-109.

Baseline gene expression in patients with chronic myeloid leukemia (CML) who received tyrosine kinase inhibitor (TKI) therapy in the phase 3 ENESTnd trial differentiated those who achieved a good response from those with a poor response at 5 years in an exploratory analysis.

The investigators developed gene-expression models based on RNA sequencing of whole blood samples collected prior to treatment with nilotinib or imatinib in study participants who completed at least 5 years of therapy, including both good responders – those who achieved a major molecular response (MMR), defined as BCR-ABL1IS (a gene sequence found in an abnormal chromosome 22) less than 0.01% by 12 months and sustained deep molecular response (DMR) by 5 years, and poor responders – those without MMR by 12 months or with BCR-ABL1IS greater than 10% at 3 months.

A model based on the comparison of gene signatures from 47 patients who achieved a molecular response of 4.5 (MR^4.5) on the International Scale (BCR-ABL1S less than 0.00032%), compared with 23 patients with a poor response, best predicted 5-year responder status (area under the receiver operating characteristic curve, 0.76), Jerald P. Radich, MD, reported during the Society of Hematologic Oncology virtual meeting.

“For this kind of work, that’s really quite good,” said Dr. Radich of the clinical research division at Fred Hutchinson Cancer Research Center, Seattle.

Notably, the differences in patient responses observed by 12 months in ENESTnd persisted for up to 10 years, he said.

The findings have potential implications for drug development and facilitation of DMR in patients on TKI therapy – a prerequisite for attempting treatment-free remission, he said.

Dr. Radich and colleagues assessed 24 clinical factors – such as Sokal risk score, TKI therapy type, age, and sex – according to responder status, and applied penalized regression to the clinical variables, to expression of 13,575 genes, and to a combination of the clinical variables and gene expression.

Clinical variables didn’t predict response in the trial, and including the clinical variables in the gene-expression model in the exploratory analysis did not improve it’s performance (AUC, 0.75). However, both the MR^4.5 plus clinical variables model and the MR^4.5-only model outperformed the clinical variables–only model (AUC, 0.59), he noted, adding: “So gene expression seems to be highly correlated with response.”

Of note, 458 genes were differentially expressed; those found in responders were most often associated with immune response, whereas those in poor responders were more likely to be associated with drug catabolism, WNT signaling, and cell cycle.

This suggests that good responders, compared with poor responders, have an activated immune system that is better able to engage after TKI therapy is administered to “cull through the heard, so to speak,” Dr. Radich said.

The findings were validated in an independent dataset of 19 good responders and 25 poor responders (AUC, 0.67 for the MR4.5 vs. poor-responder model).

A comparison of the expression of immune cell marker genes in good responders and poor responders further showed that T cells – particularly CD8 T cells, B cells, natural killer cells, and aggregate cytotoxic lymphocytes were expressed at significantly higher levels in good responders.

This was true in both the ENESTnd cohort and the validation dataset, he said.

The ENESTnd study is a randomized, open-label study comparing nilotinib and imatinib in adults with newly diagnosed Philadelphia chromosome–positive chronic-phase CML. A 5-year study update published in 2016 showed that 54% and 52% of patients in nilotinib 300- and 400-mg twice-daily arms, respectively, achieved MR^4.5, compared with 31% of those in an imatinib 400-mg once-daily arm. In the current exploratory analysis, the gene expression model differentiated between good and poor responders regardless of the TKI used, Dr. Radich said.

The findings are of note because achieving sustained deep molecular response is necessary before CML patients can attempt treatment-free remission and because biomarkers for predicting DMR have been lacking, he explained.

“These findings could really be used, potentially, for a couple of things: One is to predict response, and that could drive patient goals, expectations, and maybe drug choice,” he said.

The findings could also be used to inform clinical trials to investigate how to best treat poor responders to improve their response, he added.

“I think there’s a lot of work to be done and a lot things to chew over, and we’re hoping that we’ll have more to talk to you about in the future,” he said.

The study was sponsored by Novartis. Dr. Radich is a paid consultant for Genentech, Cepheid, Bristol-Myers Squibb, Takeda, and Novartis.

[email protected]

SOURCE: Radich JP et al. SOHO 2020, Abstract CML-109.

Soliton’s Rapid Acoustic Pulse (RAP) device, which was cleared for tattoo removal in 2019, is being investigated as an option to improve the appearance of cellulite.

“The procedure is relatively painless, without anesthesia and can easily be delegated with physician oversight,” Mathew M. Avram, MD, JD, said during the virtual annual Masters of Aesthetics Symposium. “Side effects have been minimal and transient to date. There is no down time.”

According to Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, the RAP device emits rapid acoustic pulses (shock waves) that are transmitted through the skin to rupture or “shear” the fibrotic septa. This causes the release of septa, which results in a smoothening of skin dimples.

“Basically, what you have is a repetition rate and very short rise time that provide microscopic mechanical disruption to the targeted cellular level structures and vacuoles,” Dr. Avram explained. “There’s a high leak pressure and fast repetition rate that exploits the viscoelastic nature of the tissue. You get compressed pulses from electronic filtering and the reflector shape eliminates cavitation, heat, and pain.”

The procedure takes 20-30 minutes to perform and it generates minimal heat and pain, “which is an advantage of the treatment,” he said. “It is completely noninvasive, with no incision whatsoever. No anesthetic is required. There can be physician oversight of delivery, so it is delegable, and there is no recovery time. More study is needed, and we need to stay tuned.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton. He also reported having ownership and/or shareholder interest in Cytrellis.

[email protected]

Soliton’s Rapid Acoustic Pulse (RAP) device, which was cleared for tattoo removal in 2019, is being investigated as an option to improve the appearance of cellulite.

“The procedure is relatively painless, without anesthesia and can easily be delegated with physician oversight,” Mathew M. Avram, MD, JD, said during the virtual annual Masters of Aesthetics Symposium. “Side effects have been minimal and transient to date. There is no down time.”

According to Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, the RAP device emits rapid acoustic pulses (shock waves) that are transmitted through the skin to rupture or “shear” the fibrotic septa. This causes the release of septa, which results in a smoothening of skin dimples.

“Basically, what you have is a repetition rate and very short rise time that provide microscopic mechanical disruption to the targeted cellular level structures and vacuoles,” Dr. Avram explained. “There’s a high leak pressure and fast repetition rate that exploits the viscoelastic nature of the tissue. You get compressed pulses from electronic filtering and the reflector shape eliminates cavitation, heat, and pain.”

The procedure takes 20-30 minutes to perform and it generates minimal heat and pain, “which is an advantage of the treatment,” he said. “It is completely noninvasive, with no incision whatsoever. No anesthetic is required. There can be physician oversight of delivery, so it is delegable, and there is no recovery time. More study is needed, and we need to stay tuned.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton. He also reported having ownership and/or shareholder interest in Cytrellis.

[email protected]

Soliton’s Rapid Acoustic Pulse (RAP) device, which was cleared for tattoo removal in 2019, is being investigated as an option to improve the appearance of cellulite.

“The procedure is relatively painless, without anesthesia and can easily be delegated with physician oversight,” Mathew M. Avram, MD, JD, said during the virtual annual Masters of Aesthetics Symposium. “Side effects have been minimal and transient to date. There is no down time.”

According to Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, the RAP device emits rapid acoustic pulses (shock waves) that are transmitted through the skin to rupture or “shear” the fibrotic septa. This causes the release of septa, which results in a smoothening of skin dimples.

“Basically, what you have is a repetition rate and very short rise time that provide microscopic mechanical disruption to the targeted cellular level structures and vacuoles,” Dr. Avram explained. “There’s a high leak pressure and fast repetition rate that exploits the viscoelastic nature of the tissue. You get compressed pulses from electronic filtering and the reflector shape eliminates cavitation, heat, and pain.”

The procedure takes 20-30 minutes to perform and it generates minimal heat and pain, “which is an advantage of the treatment,” he said. “It is completely noninvasive, with no incision whatsoever. No anesthetic is required. There can be physician oversight of delivery, so it is delegable, and there is no recovery time. More study is needed, and we need to stay tuned.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton. He also reported having ownership and/or shareholder interest in Cytrellis.

[email protected]

The school year has begun, but for most families it is a school year without precedent. Parents have to monitor and support their children through school days that are partially or completely virtual, juggling sudden class transitions, troubleshooting technology, and trying to manage lessons and assignments. Most related activities such as sports and orchestra are cancelled. Parents themselves are anxious about completing their work, if they have jobs at all. On top of this, all of us have faced months of challenge and disruption with virtually no relief, with regard to seeing friends, traveling, or going out to dinner or a movie. For your patients with ADHD, the challenges of this school year will be even more difficult. Offering parents some guidance about how to approach and manage these challenges can support their adaptation and lessen the chances of compounded problems by the time in-person school resumes.

FatCamera/E+

Children with ADHD, particularly those in elementary school, are managing symptoms of difficulty shifting their attention, sustaining focus on less-engaging material, and motor hyperactivity. They often have difficulty with organization and planning, working memory, and impulse control. Even with effective medication management, they typically are dependent on external cues and support to manage the demands of school. They benefit from attentive teachers who can redirect their attention, offer serial prompts before transitions, and provide patient support, reassurance, and confidence when they grow frustrated. And it often is easier for teachers to do this than for parents, as they have years of experience and training, and the support of their professionals in the school setting. And of course they are less likely to personalize these challenges than are parents, who are likely to feel worried, guilty, or discouraged by the child’s persistent difficulties with attention. Parents who are stressed or who may be managing difficulties with attention themselves – as ADHD is one of the more heritable psychiatric disorders – will be vulnerable to feeling frustration and losing their temper.

Suggest to the parents of your patients with ADHD that there will be frustrations and challenges as they manage the learning curve of virtual school with their children. Increasing the dose of an effective stimulant may be tempting, but there are a few strategies that may better help the children adapt to a virtual classroom without too much distress.
 

Promote good sleep patterns

Adequate, restful sleep is critical to our physical and psychological health and to healthy development. Children with ADHD are prone to sleep difficulties, and stimulants may exacerbate these.

deyangeorgiev/thinkstockphotos.com

So, it is critical that parents prioritize setting and maintaining healthy routines around sleep. All screens should power down at least 1 hour before lights out, and parents can help their children know when to accept “good enough” homework, so they also may get good enough sleep.

Daily physical activity helps enormously with restful sleep. A warm bath or shower and quiet reading (not homework!) can help wired kids unwind and be truly ready for lights out. Bedtime may start to slide later as life’s routines are disrupted with work and school happening at home, but it is important to maintain a consistent bedtime that will allow for 8-10 hours of sleep.
 

Create routines around the “school day”

Good schools involve a predictable rhythm and a lot of caring adults engaging with children. They have very consistent routines at the start of each day, and families can create their own to offer structure and cues to their children.

Start the day with a consistent wake up time and routine plus a healthy breakfast. Take advantage of the extra time that no commute to school or bus ride allow, whether by supporting more sleep, cooking a hot breakfast together, or by letting the children engage in a beloved activity, such as listening to music, reading a comic book, or working on a craft before the computer goes on.

The routine should be centered on the rhythm of the school, and realistic for parents. It matters most that it is consistent, incorporates nutritious food and exercise, and is pleasant and even fun.
 

Set the stage

Teachers will often put their students with ADHD in the front of the class, so they can offer prompts and so the students are less distracted by peers. Consider where in the home is a good spot for the children, one that minimizes distractions and where a parent is near enough to support and monitor them.

Parents might want to avoid rooms with a lot of toys or games that may tempt children, and children will need to be apart from (noisy) siblings. If they forget to mute themselves or are tempted to open another window on their computer, it is helpful for a parent to be near enough to be unobtrusively following along. Parents will hear the sounds of trouble and be able to help if their children get lost in an assignment or are otherwise off-track.
 

Create reasonable expectations and positive rewards

Reassure parents that this adjustment is going to be hard for all children and families. Now is not the season for perfectionism or focusing too intensely on mastering a challenging subject.

Reasonable goals for the first month might be for the child to get some enjoyment from school and to get better at specific tasks (being on time, managing the technology, asking for help when needed).

Parents may even set this goal with their children: “What do you want to be better at by the end of the first month?” If children with ADHD improve at managing the distractions of a virtual class, they will have accomplished a great deal cognitively. It will be hard work for them.

So parents should think about what reward can come at the end of each school day, whether a walk outside together, a game of Uno, or even an afterschool treat together, so children get a sense of success for even incremental adaptation.
 

Build in breaks from the screen

Spending much more than an hour in a virtual interaction is taxing even for adult attention spans. Parents should feel empowered to speak with their children’s teachers to find ways to build in regular 10- to 15-minute breaks during which their children can have a snack, take a bathroom break, or get their wiggles out.

Ensure there is some physical activity

Recess is usually the most important class of the day in elementary school, and especially for children with ADHD. If parents can make physical activity part of their children’s routines, breaks, and afterschool rewards, their attention, energy, and sleep will be improved.

FatCamera/E+

They might do a workout with the child for 20 minutes before school starts, go for a short walk, or do jumping jacks during breaks. And getting outside to kick a ball, go for a swim, or otherwise get the heart rate up in the sunshine will be the most important thing parents do for their children after protecting their sleep.
 

Know your child

Remember parents are the experts on their children. School is the setting in which children are both cultivating their strengths and facing challenges. Ask the parents what has been most challenging for their children about school and what was most cherished about it.

Parents should get creative to cultivate their children’s strengths. If a child adores art, it will be so important to try to provide that experience during this school year. There might be other virtual resources (virtual museum tours, YouTube art lessons), a local teacher who can offer socially distant lessons, or even another student who might be able to safely share a teacher – getting a creative and social outlet together.

Are there special teachers that the children are missing? Maybe there is a way to send them emails or have some virtual time with them each week.

If a child struggles with the classroom but excells on the soccer pitch, it will be critical to find a physically distant way for the child to develop that strength, whether with a small, informal practice or a new physical undertaking.

Likewise, parents may need to look elsewhere to help their children manage important challenges. Whether a child is learning how to face anxiety or improve social skills, virtual school might seem like a relief as it takes the pressure off. Help parents consider alternate ways that their children could continue to work on these developmental projects while school is virtual, so they don’t lose ground developmentally.

If parents can set reasonable goals, be patient, and focus on the daily routines, and consider the child’s individual developmental strengths and challenges, they may be better able to manage this challenging year. They may even find improved connection, patience, and perspective for both themselves and their children.
 

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Neither Dr. Swick nor Dr. Jellinek had any relevant financial disclosures. Email them at [email protected].

The school year has begun, but for most families it is a school year without precedent. Parents have to monitor and support their children through school days that are partially or completely virtual, juggling sudden class transitions, troubleshooting technology, and trying to manage lessons and assignments. Most related activities such as sports and orchestra are cancelled. Parents themselves are anxious about completing their work, if they have jobs at all. On top of this, all of us have faced months of challenge and disruption with virtually no relief, with regard to seeing friends, traveling, or going out to dinner or a movie. For your patients with ADHD, the challenges of this school year will be even more difficult. Offering parents some guidance about how to approach and manage these challenges can support their adaptation and lessen the chances of compounded problems by the time in-person school resumes.

FatCamera/E+

Children with ADHD, particularly those in elementary school, are managing symptoms of difficulty shifting their attention, sustaining focus on less-engaging material, and motor hyperactivity. They often have difficulty with organization and planning, working memory, and impulse control. Even with effective medication management, they typically are dependent on external cues and support to manage the demands of school. They benefit from attentive teachers who can redirect their attention, offer serial prompts before transitions, and provide patient support, reassurance, and confidence when they grow frustrated. And it often is easier for teachers to do this than for parents, as they have years of experience and training, and the support of their professionals in the school setting. And of course they are less likely to personalize these challenges than are parents, who are likely to feel worried, guilty, or discouraged by the child’s persistent difficulties with attention. Parents who are stressed or who may be managing difficulties with attention themselves – as ADHD is one of the more heritable psychiatric disorders – will be vulnerable to feeling frustration and losing their temper.

Suggest to the parents of your patients with ADHD that there will be frustrations and challenges as they manage the learning curve of virtual school with their children. Increasing the dose of an effective stimulant may be tempting, but there are a few strategies that may better help the children adapt to a virtual classroom without too much distress.
 

Promote good sleep patterns

Adequate, restful sleep is critical to our physical and psychological health and to healthy development. Children with ADHD are prone to sleep difficulties, and stimulants may exacerbate these.

deyangeorgiev/thinkstockphotos.com

So, it is critical that parents prioritize setting and maintaining healthy routines around sleep. All screens should power down at least 1 hour before lights out, and parents can help their children know when to accept “good enough” homework, so they also may get good enough sleep.

Daily physical activity helps enormously with restful sleep. A warm bath or shower and quiet reading (not homework!) can help wired kids unwind and be truly ready for lights out. Bedtime may start to slide later as life’s routines are disrupted with work and school happening at home, but it is important to maintain a consistent bedtime that will allow for 8-10 hours of sleep.
 

Create routines around the “school day”

Good schools involve a predictable rhythm and a lot of caring adults engaging with children. They have very consistent routines at the start of each day, and families can create their own to offer structure and cues to their children.

Start the day with a consistent wake up time and routine plus a healthy breakfast. Take advantage of the extra time that no commute to school or bus ride allow, whether by supporting more sleep, cooking a hot breakfast together, or by letting the children engage in a beloved activity, such as listening to music, reading a comic book, or working on a craft before the computer goes on.

The routine should be centered on the rhythm of the school, and realistic for parents. It matters most that it is consistent, incorporates nutritious food and exercise, and is pleasant and even fun.
 

Set the stage

Teachers will often put their students with ADHD in the front of the class, so they can offer prompts and so the students are less distracted by peers. Consider where in the home is a good spot for the children, one that minimizes distractions and where a parent is near enough to support and monitor them.

Parents might want to avoid rooms with a lot of toys or games that may tempt children, and children will need to be apart from (noisy) siblings. If they forget to mute themselves or are tempted to open another window on their computer, it is helpful for a parent to be near enough to be unobtrusively following along. Parents will hear the sounds of trouble and be able to help if their children get lost in an assignment or are otherwise off-track.
 

Create reasonable expectations and positive rewards

Reassure parents that this adjustment is going to be hard for all children and families. Now is not the season for perfectionism or focusing too intensely on mastering a challenging subject.

Reasonable goals for the first month might be for the child to get some enjoyment from school and to get better at specific tasks (being on time, managing the technology, asking for help when needed).

Parents may even set this goal with their children: “What do you want to be better at by the end of the first month?” If children with ADHD improve at managing the distractions of a virtual class, they will have accomplished a great deal cognitively. It will be hard work for them.

So parents should think about what reward can come at the end of each school day, whether a walk outside together, a game of Uno, or even an afterschool treat together, so children get a sense of success for even incremental adaptation.
 

Build in breaks from the screen

Spending much more than an hour in a virtual interaction is taxing even for adult attention spans. Parents should feel empowered to speak with their children’s teachers to find ways to build in regular 10- to 15-minute breaks during which their children can have a snack, take a bathroom break, or get their wiggles out.

Ensure there is some physical activity

Recess is usually the most important class of the day in elementary school, and especially for children with ADHD. If parents can make physical activity part of their children’s routines, breaks, and afterschool rewards, their attention, energy, and sleep will be improved.

FatCamera/E+

They might do a workout with the child for 20 minutes before school starts, go for a short walk, or do jumping jacks during breaks. And getting outside to kick a ball, go for a swim, or otherwise get the heart rate up in the sunshine will be the most important thing parents do for their children after protecting their sleep.
 

Know your child

Remember parents are the experts on their children. School is the setting in which children are both cultivating their strengths and facing challenges. Ask the parents what has been most challenging for their children about school and what was most cherished about it.

Parents should get creative to cultivate their children’s strengths. If a child adores art, it will be so important to try to provide that experience during this school year. There might be other virtual resources (virtual museum tours, YouTube art lessons), a local teacher who can offer socially distant lessons, or even another student who might be able to safely share a teacher – getting a creative and social outlet together.

Are there special teachers that the children are missing? Maybe there is a way to send them emails or have some virtual time with them each week.

If a child struggles with the classroom but excells on the soccer pitch, it will be critical to find a physically distant way for the child to develop that strength, whether with a small, informal practice or a new physical undertaking.

Likewise, parents may need to look elsewhere to help their children manage important challenges. Whether a child is learning how to face anxiety or improve social skills, virtual school might seem like a relief as it takes the pressure off. Help parents consider alternate ways that their children could continue to work on these developmental projects while school is virtual, so they don’t lose ground developmentally.

If parents can set reasonable goals, be patient, and focus on the daily routines, and consider the child’s individual developmental strengths and challenges, they may be better able to manage this challenging year. They may even find improved connection, patience, and perspective for both themselves and their children.
 

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Neither Dr. Swick nor Dr. Jellinek had any relevant financial disclosures. Email them at [email protected].

The school year has begun, but for most families it is a school year without precedent. Parents have to monitor and support their children through school days that are partially or completely virtual, juggling sudden class transitions, troubleshooting technology, and trying to manage lessons and assignments. Most related activities such as sports and orchestra are cancelled. Parents themselves are anxious about completing their work, if they have jobs at all. On top of this, all of us have faced months of challenge and disruption with virtually no relief, with regard to seeing friends, traveling, or going out to dinner or a movie. For your patients with ADHD, the challenges of this school year will be even more difficult. Offering parents some guidance about how to approach and manage these challenges can support their adaptation and lessen the chances of compounded problems by the time in-person school resumes.

FatCamera/E+

Children with ADHD, particularly those in elementary school, are managing symptoms of difficulty shifting their attention, sustaining focus on less-engaging material, and motor hyperactivity. They often have difficulty with organization and planning, working memory, and impulse control. Even with effective medication management, they typically are dependent on external cues and support to manage the demands of school. They benefit from attentive teachers who can redirect their attention, offer serial prompts before transitions, and provide patient support, reassurance, and confidence when they grow frustrated. And it often is easier for teachers to do this than for parents, as they have years of experience and training, and the support of their professionals in the school setting. And of course they are less likely to personalize these challenges than are parents, who are likely to feel worried, guilty, or discouraged by the child’s persistent difficulties with attention. Parents who are stressed or who may be managing difficulties with attention themselves – as ADHD is one of the more heritable psychiatric disorders – will be vulnerable to feeling frustration and losing their temper.

Suggest to the parents of your patients with ADHD that there will be frustrations and challenges as they manage the learning curve of virtual school with their children. Increasing the dose of an effective stimulant may be tempting, but there are a few strategies that may better help the children adapt to a virtual classroom without too much distress.
 

Promote good sleep patterns

Adequate, restful sleep is critical to our physical and psychological health and to healthy development. Children with ADHD are prone to sleep difficulties, and stimulants may exacerbate these.

deyangeorgiev/thinkstockphotos.com

So, it is critical that parents prioritize setting and maintaining healthy routines around sleep. All screens should power down at least 1 hour before lights out, and parents can help their children know when to accept “good enough” homework, so they also may get good enough sleep.

Daily physical activity helps enormously with restful sleep. A warm bath or shower and quiet reading (not homework!) can help wired kids unwind and be truly ready for lights out. Bedtime may start to slide later as life’s routines are disrupted with work and school happening at home, but it is important to maintain a consistent bedtime that will allow for 8-10 hours of sleep.
 

Create routines around the “school day”

Good schools involve a predictable rhythm and a lot of caring adults engaging with children. They have very consistent routines at the start of each day, and families can create their own to offer structure and cues to their children.

Start the day with a consistent wake up time and routine plus a healthy breakfast. Take advantage of the extra time that no commute to school or bus ride allow, whether by supporting more sleep, cooking a hot breakfast together, or by letting the children engage in a beloved activity, such as listening to music, reading a comic book, or working on a craft before the computer goes on.

The routine should be centered on the rhythm of the school, and realistic for parents. It matters most that it is consistent, incorporates nutritious food and exercise, and is pleasant and even fun.
 

Set the stage

Teachers will often put their students with ADHD in the front of the class, so they can offer prompts and so the students are less distracted by peers. Consider where in the home is a good spot for the children, one that minimizes distractions and where a parent is near enough to support and monitor them.

Parents might want to avoid rooms with a lot of toys or games that may tempt children, and children will need to be apart from (noisy) siblings. If they forget to mute themselves or are tempted to open another window on their computer, it is helpful for a parent to be near enough to be unobtrusively following along. Parents will hear the sounds of trouble and be able to help if their children get lost in an assignment or are otherwise off-track.
 

Create reasonable expectations and positive rewards

Reassure parents that this adjustment is going to be hard for all children and families. Now is not the season for perfectionism or focusing too intensely on mastering a challenging subject.

Reasonable goals for the first month might be for the child to get some enjoyment from school and to get better at specific tasks (being on time, managing the technology, asking for help when needed).

Parents may even set this goal with their children: “What do you want to be better at by the end of the first month?” If children with ADHD improve at managing the distractions of a virtual class, they will have accomplished a great deal cognitively. It will be hard work for them.

So parents should think about what reward can come at the end of each school day, whether a walk outside together, a game of Uno, or even an afterschool treat together, so children get a sense of success for even incremental adaptation.
 

Build in breaks from the screen

Spending much more than an hour in a virtual interaction is taxing even for adult attention spans. Parents should feel empowered to speak with their children’s teachers to find ways to build in regular 10- to 15-minute breaks during which their children can have a snack, take a bathroom break, or get their wiggles out.

Ensure there is some physical activity

Recess is usually the most important class of the day in elementary school, and especially for children with ADHD. If parents can make physical activity part of their children’s routines, breaks, and afterschool rewards, their attention, energy, and sleep will be improved.

FatCamera/E+

They might do a workout with the child for 20 minutes before school starts, go for a short walk, or do jumping jacks during breaks. And getting outside to kick a ball, go for a swim, or otherwise get the heart rate up in the sunshine will be the most important thing parents do for their children after protecting their sleep.
 

Know your child

Remember parents are the experts on their children. School is the setting in which children are both cultivating their strengths and facing challenges. Ask the parents what has been most challenging for their children about school and what was most cherished about it.

Parents should get creative to cultivate their children’s strengths. If a child adores art, it will be so important to try to provide that experience during this school year. There might be other virtual resources (virtual museum tours, YouTube art lessons), a local teacher who can offer socially distant lessons, or even another student who might be able to safely share a teacher – getting a creative and social outlet together.

Are there special teachers that the children are missing? Maybe there is a way to send them emails or have some virtual time with them each week.

If a child struggles with the classroom but excells on the soccer pitch, it will be critical to find a physically distant way for the child to develop that strength, whether with a small, informal practice or a new physical undertaking.

Likewise, parents may need to look elsewhere to help their children manage important challenges. Whether a child is learning how to face anxiety or improve social skills, virtual school might seem like a relief as it takes the pressure off. Help parents consider alternate ways that their children could continue to work on these developmental projects while school is virtual, so they don’t lose ground developmentally.

If parents can set reasonable goals, be patient, and focus on the daily routines, and consider the child’s individual developmental strengths and challenges, they may be better able to manage this challenging year. They may even find improved connection, patience, and perspective for both themselves and their children.
 

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Neither Dr. Swick nor Dr. Jellinek had any relevant financial disclosures. Email them at [email protected].

The 2019-2020 term of the US Supreme Court was remarkable by any standard. An extraordinary number of important cases made it “a buffet of blockbusters.”¹ 

We look first at several cases that will be of particular interest to ObGyns. Then we look briefly at a number of other important cases that affect the medical profession as a whole and the direction of the country (see “Other significant US Supreme Court decisions”), and finally we conclude with an analysis of this term and a forecast for the next. 

We chose cases in which specialty organizations, such as the American College of Obstetricians and Gynecologists (ACOG), or organized medicine (the American Medical Association [AMA], the Association of American Medical Colleges [AAMC], or the American Hospital Association [AHA]), took a special interest by filing “amicus curiae” (friend of the court) briefs with the Supreme Court. These briefs are filed by an organization or person who is not a party to the case but who may have important information to convey to the Court. Because these briefs represent a significant commitment of money, time, and effort, they are usually not undertaken lightly. 

Decisions concerning abortion

June v Russo

Decided June 29, 2020, June v Russo involved a Louisiana statute that required abortion providers have “active admitting privileges at a hospital” within 30 miles of where the abortion is performed.² The Court decided a case in 2016 (from Texas) that involved almost the same statutory provision, so it might seem like an easy ruling.³ But Justice Kennedy (the deciding vote in 2016) has been replaced by Justice Gorsuch, so the outcome was uncertain. It was a difficult case, with a total of 5 opinions covering 138 pages and a “surprise” from the Chief Justice. 

The Court, in a 5-4 decision, struck down the Louisiana law, but there was no majority opinion. Four justices in the plurality emphasized that the Louisiana law (like the Texas law) substantially burdened the right to abortion without any corresponding benefit to the health of the women seeking abortions. (Under earlier Court precedents, “undue burdens” on abortion are unconstitutional.⁴) Justice Breyer noted that the state could not present even one example in which a woman would have had better treatment if her doctor had admitting privileges. For a variety of reasons, admitting privileges were cumbersome for abortion providers to obtain; therefore, enforcing the law had little or no benefit, but significant risk of reduced availability of abortion services.

In June v Russo, Chief Justice Roberts literally became the “swing vote”—the fifth vote to strike down the Louisiana law. In 2016, he had voted the other way—to uphold essentially the same law (in Texas) that he struck down here. He attributed his switch to precedent (the general obligation of courts to follow prior decisions). He disagreed with the earlier decision, but felt bound by it. 

This should be the end of the abortion provider “hospital privileges requirements” that a number of states have passed. States seeking to nibble away at abortion rights will undoubtedly look elsewhere. Beyond that, it is difficult, from this case, to discern the future of abortion rights. 

ACOG was the lead in amicus briefs urging the Court to strike down the Louisiana law. ACOG (with others) was one of only a handful of organizations filing a brief urging the Court to agree to hear the case.⁵ When the Court did agree to hear the case (“granted certiorari”), ACOG and a number of other medical organizations filed a formal amicus brief on the merits of the case.⁶ The brief made 2 arguments: First, that this case was essentially decided in Whole Woman’s Health in 2016 (the Texas case) and, second, that “an admitting privileges requirement is not medically necessary” and “clinicians who provide abortions are unable to obtain admitting privileges for reasons unrelated to their ability to safely and competently perform abortions.” Justice Breyer cited the ACOG brief twice.

The American Association of Pro-Life Obstetricians and Gynecologists also filed an amicus brief.⁷ The brief was directed solely at arguing that ACOG was not presenting reliable science. It summarized, “The American College of Obstetricians and Gynecologists has always presented itself to the Court as a source of objective medical knowledge. However, when it comes to abortion, the College today is primarily a pro-abortion political advocacy organization.” That brief concluded that the “Court should read ACOG’s amicus brief not as an authoritative recitation of settled science, but as a partisan advocacy paper on behalf of a mere subset of American obstetricians and gynecologists.” 

The Association of American Physicians and Surgeons (which should not be confused with the “National Board of Physicians and Surgeons”) also filed an amicus brief. The brief argued, “Abortion, like other outpatient surgical procedures, sometimes results in patient hospitalization. Requiring abortion providers to maintain admitting privileges will improve communication between physicians in the transfer of patients to the hospital and allow them to participate in the care of their patients while in the hospital, in line with their ethical duty to ensure their patients’ continuity of care.”⁸

Continue to: Ultrasonography requirement for abortion...

In another abortion case, the Court was asked to review a Kentucky abortion statute requiring that an ultrasound image be shown to the woman as part of informed consent for an abortion.⁹ ACOG filed an amicus brief in favor of a review, but the Court declined to hear the case.^10,11 

Contraception considerations

The Affordable Care Act (ACA) has an ambiguous provision regarding no-cost “preventive care and screenings” for women. The ACA does not, however, specify contraceptive coverage.¹² Several departments and the Health Resources and Services Administration (collectively referred to as “HRSA”) interpreted the provision to include contraception, but from the start there were religious objections. HRSA eventually provided an exemption regarding contraception for employers (nonprofits and for-profits with no publicly traded components) that had “sincerely held moral” objections to providing forms of contraceptive coverage. That regulation was again before the Court this term in Little Sisters of the Poor Saints Peter and Paul Home v Pennsylvania.¹³ 

In a 7-2 decision, the Court held that the ACA gave HRSA authority to adopt regulations related to the undefined term “preventive care.” Therefore, it found that HRSA could exempt those with religious objections from participation in providing contraceptive coverage. ACOG and other medical groups filed an amicus brief arguing that contraception is an essential preventive service. “Contraception not only helps to prevent unintended pregnancy, but also helps to protect the health and well-being of women and their children.”¹⁴ It was cited only by Justice Ginsburg in her dissent.¹⁵ 

Deferred Action for Childhood Arrivals (DACA)

The AAMC, ACOG, AMA, and many other organizations filed an amicus brief¹⁶ in Department of Homeland Security v Regents of University of California.¹⁷ The case raised the question of whether a decision to end the DACA program followed the appropriate administrative procedures. In 2012, the Obama administration issued a “memorandum” establishing DACA (without congressional approval or formal rulemaking). A lower court decision barring implementation of DACA was upheld by the Supreme Court in 2016 on a 4-4 vote.¹⁸ In 2017, the Trump administration moved to end DACA. 

In a 5-4 decision, the Court held that the explanation for ending DACA was inadequate, and violated the Administrative Procedures Act, so DACA could continue until the administration redid the repeal, following the proper procedures. The decision of the Court dealt solely with the process by which the rescission took place—there was general agreement that the administration had the right to rescind it if the procedure (with legitimate reasons) was proper.

The brief for the medical groups argued that the failure of the regulation to consider “reliance interests” would have especially difficult consequences in the medical fields. It noted, “At this moment, an estimated 27,000 health care workers and support staff depend on DACA for their authorization to work in the United States. Among those 27,000 are nurses, dentists, pharmacists, physician assistants, home health aides, technicians, and others. The number also includes nearly 200 medical students, medical residents, and physicians who depend on DACA for their eligibility to practice medicine.”¹⁶ The brief was not cited by the Court, but the reliance interest the brief spoke about was an important part of the case.

Continue to: Employment discrimination against gay and transgender employees...

Federal law (“Title VII”) makes it illegal for an employer to “discriminate against any individual because of race, color, religion, sex, or national origin.”¹⁹ The question this term was whether discrimination based on sexual orientation or sexual identity is within the statute’s meaning of “sex.” By a 6-3 majority, the Court held that Title VII applies both to orientation and identity. (This was an interpretation of the statute, not a broad constitutional ruling.)

The majority reasoned that “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex. Consider, for example, an employer with 2 employees, both of whom are attracted to men.” If the employer fires the gay employee, “the employer discriminates against him for traits or actions it tolerates in his female colleague.”²⁰ 

AMA and a number of other medical organizations filed an amicus brief in the case.²¹ The core of the argument of the brief was, “Employment discrimination against transgender people frustrates the treatment of gender dysphoria by preventing transgender individuals from living openly in accordance with their true gender identity and impeding access to needed medical care. Experiencing discrimination in one of the most important aspects of adult life—employment—makes it nearly impossible to live in full congruence with one’s gender identity. The fear of facing such discrimination alone can prompt transgender individuals to hide their gender identity, directly thwarting the goal of social transition…. Lack of treatment, in turn, increases the rate of negative mental health outcomes, substance abuse, and suicide.” The brief was not cited in the opinions in the case.

This decision is likely to have great impact on many aspects of American life. In the employment area, it is now a matter of course that employers may not discriminate based on orientation or identity in any employment decisions including hiring, firing, compensation, fringe benefits, etc. Harassment based on identity or orientation may similarly be an employment law violation. The decision also likely means that giving employment preferences to gay employees would now be as illegal as would be giving preferences to straight employees. (Limited exceptions, notably to some religious organization employees, are not included in anti-discrimination laws.)²² 

The importance of the decision goes well beyond employment, however. More than 100 federal statutes are in place that prohibit “discrimination because of sex.” It is now likely that these statutes will be interpreted as prohibiting discrimination related to sexual orientation and identification. 

Additional cases of interest 

HIV/AIDS International Program

A major US program fighting HIV/AIDS worldwide—the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (aka the Leadership Act)—has provided billions of dollars to agencies abroad.²³ Nongovernmental organizations (NGOs) receiving funds under the program must agree to have a “policy explicitly opposing prostitution and sex trafficking” (known as the “Policy Requirement”). Some grant recipients in foreign countries, generally affiliates of US NGOs, do not want to have such a policy and challenged the policy requirement as a violation of First Amendment right of free speech. The Court held that it is a well-settled principle that “foreign citizens outside US territory do not possess rights under the US Constitution.”²⁴ Nor do organizations become entitled to such rights as a result of an affiliation with US organizations. This decision means that foreign organizations are free not to have the required policies, but they will be ineligible for funds under the Leadership Act. 

Continue to: ACA government debts edition...

The ACA was before the Court, yet again. To encourage private insurers to participate in online health insurance exchanges, the ACA provided that the federal government would share in insurance company losses for 3 years.²⁵ The Act, however, did not appropriate any money for these “risk corridors,” and insurance companies  lost $12 billion. 

Congress (after the 2010 election) prohibited any appropriated funds from being used to pay insurance companies for their risk corridor losses. Four insurance companies sued the United States, seeking reimbursements for their losses. This term the Court held that the government must pay for their losses under the ACA.²⁶ The Court said that Congress could have expressly repealed the risk corridor obligation (in the appropriation bill), but instead had only prohibited the expenditure of the money, which the Court said did not amount to an implied repeal of the obligation. We will see that ACA will be back before the Court again next term in California v Texas (discussed below).

Child custody and international abduction

The Hague Convention on the Civil Aspects of International Child Abduction (to which the United States is a party) provides that the courts of the country where the child has “habitual residence” have jurisdiction to decide custody.²⁷ If a parent takes the child to another country, that country is obligated to return the child to the country of “habitual residence.” 

This term the Court was called upon to define “habitual residence.” The Court held that determining habitual residence depends on the “totality of the circumstances,” and that “locating a child’s home is a fact-driven inquiry,” and that “courts must be sensitive to the unique circumstances of the case and informed by common sense.”²⁸ An exception to the Convention’s obligation to return a child to the country of habitual residence is where “there is a grave risk that [the] return would expose the child to physical or psychological harm or otherwise place the child in an intolerable situation.”²⁹ Who the parent is can affect many aspects of legal authority over the child, including consent to medical care, and the right to receive information concerning care. 

Analysis of the term

The term began October 7, 2019, and adjourned July 9, 2020, somewhat later than usual because of coronavirus disease 2019 (COVID-19). During the term, the Court decided 60 cases, including 53 “signed” merit opinions after oral argument—the lowest number of decided cases in many years.30 Of those 60 cases, 22 (35%) were unanimous, and 13 (22%) resulted in a 5-4 split.³⁰ Ten-year averages are 48% unanimous and 20% with 5-4 decisions.³⁰

Chief Justice Roberts was the central focus of the term. He presided over the impeachment trial of President Trump in the Senate early in the term. He also presided over the Court’s accommodations of the COVID-19 pandemic. He is the “median,” or “swing,” justice. He was in the majority in 12 of the 13 cases with 5-4 decisions.³⁰ He was in the majority in 97% of all cases and in 95% of “divided cases”—the highest of any of the justices this term.³⁰ In some of the most critical decisions, Chief Justice Roberts sided with the “liberal” wing, including on cases concerning abortion, gay and transgender employment, DACA, and 2 Presidential subpoena cases. More often (in 9 of the 5-4 decisions), however, he sided with the more conservative justices.³⁰ Justice Kavanaugh agreed with Chief Justice Roberts most often (in 93% of all cases).³⁰ Among the others, these justices agreed with each other 90% or more of the time: Justices Ginsburg and Breyer (93%), Justices Alito and Thomas (92%), and Justices Breyer and Kagan (90%).³⁰

Continue to: COVID-19 and the Court...

Some of the biggest news of the term came not from the law, but from medicine in the form of  COVID-19. The Court was in the process of preparing a final period of important arguments when, on March 16, it announced that it was postponing further arguments. The Court rescheduled 10 oral arguments that were held by telephone (other cases were held over to the next term). The phone arguments, during the first 2 weeks of May, necessitated a change in format. Each justice was called on (in order of seniority) by the Chief Justice to ask questions. This was in contrast to the free-for-all questions that usually characterize in-person arguments. These arguments were broadcast live—something that had never been done before. Public access was, on balance, a good thing. There were a couple failures to unmute, and there was “the flush heard round the world” in the middle of one argument, but otherwise the arguments went off with few hitches.³¹

Looking ahead

By the end of the term, no justice had announced an intention to retire from the Court. On September 18, however, Justice Ruth Bader Ginsburg passed away. In 2009, she had been diagnosed with early-stage pancreatic cancer. This term she had been hospitalized twice, and at the end of the term, she announced a recurrence of pancreatic cancer, which was being treated with chemotherapy. See “RBG: The woman, the legacy” for a tribute to this remarkable woman, lawyer, and justice.

Justice Ginsburg’s death, occurring in the middle of a presidential campaign, ignited a political firestorm concerning her successor. The outcome of selecting and confirming her successor and the political fallout were not immediately apparent. Justice Ginsburg was confirmed just 7 weeks after her nomination by President Clinton, by a vote of 96-3. But those days of Senate consensus are not the current norm.

The next term (called the “October 2020 Term”) will begin on October 5, 2020. The Court will begin with 8 justices and, depending on the nomination process, may operate with 8 justices for some time. When there is a “tie” vote in the Court, the lower court decision is upheld. The Court has been short-handed several times in the past and, with few exceptions, has managed the cases successfully.

The Court has announced that initial arguments will be telephonic. It already has taken a number of cases. The constitutionality of the individual mandate (coverage) in the ACA will once again be before the Court, and that already has produced a flood of amicus briefs from health-related organizations.³² Among other upcoming issues are cases related to state regulation of pharmacy benefit managers, gay rights and foster care, sentencing of juveniles to life in prison without the possibility of parole, a face-off between Google and Oracle on software copyrights, and arbitration. In addition, some of the issues we saw this term will reappear, with more on robocalls, religious freedom and Catholic charities, and immigration and removal cases.
 

The 2019-2020 term of the US Supreme Court was remarkable by any standard. An extraordinary number of important cases made it “a buffet of blockbusters.”¹ 

We look first at several cases that will be of particular interest to ObGyns. Then we look briefly at a number of other important cases that affect the medical profession as a whole and the direction of the country (see “Other significant US Supreme Court decisions”), and finally we conclude with an analysis of this term and a forecast for the next. 

We chose cases in which specialty organizations, such as the American College of Obstetricians and Gynecologists (ACOG), or organized medicine (the American Medical Association [AMA], the Association of American Medical Colleges [AAMC], or the American Hospital Association [AHA]), took a special interest by filing “amicus curiae” (friend of the court) briefs with the Supreme Court. These briefs are filed by an organization or person who is not a party to the case but who may have important information to convey to the Court. Because these briefs represent a significant commitment of money, time, and effort, they are usually not undertaken lightly. 

Decisions concerning abortion

June v Russo

Decided June 29, 2020, June v Russo involved a Louisiana statute that required abortion providers have “active admitting privileges at a hospital” within 30 miles of where the abortion is performed.² The Court decided a case in 2016 (from Texas) that involved almost the same statutory provision, so it might seem like an easy ruling.³ But Justice Kennedy (the deciding vote in 2016) has been replaced by Justice Gorsuch, so the outcome was uncertain. It was a difficult case, with a total of 5 opinions covering 138 pages and a “surprise” from the Chief Justice. 

The Court, in a 5-4 decision, struck down the Louisiana law, but there was no majority opinion. Four justices in the plurality emphasized that the Louisiana law (like the Texas law) substantially burdened the right to abortion without any corresponding benefit to the health of the women seeking abortions. (Under earlier Court precedents, “undue burdens” on abortion are unconstitutional.⁴) Justice Breyer noted that the state could not present even one example in which a woman would have had better treatment if her doctor had admitting privileges. For a variety of reasons, admitting privileges were cumbersome for abortion providers to obtain; therefore, enforcing the law had little or no benefit, but significant risk of reduced availability of abortion services.

In June v Russo, Chief Justice Roberts literally became the “swing vote”—the fifth vote to strike down the Louisiana law. In 2016, he had voted the other way—to uphold essentially the same law (in Texas) that he struck down here. He attributed his switch to precedent (the general obligation of courts to follow prior decisions). He disagreed with the earlier decision, but felt bound by it. 

This should be the end of the abortion provider “hospital privileges requirements” that a number of states have passed. States seeking to nibble away at abortion rights will undoubtedly look elsewhere. Beyond that, it is difficult, from this case, to discern the future of abortion rights. 

ACOG was the lead in amicus briefs urging the Court to strike down the Louisiana law. ACOG (with others) was one of only a handful of organizations filing a brief urging the Court to agree to hear the case.⁵ When the Court did agree to hear the case (“granted certiorari”), ACOG and a number of other medical organizations filed a formal amicus brief on the merits of the case.⁶ The brief made 2 arguments: First, that this case was essentially decided in Whole Woman’s Health in 2016 (the Texas case) and, second, that “an admitting privileges requirement is not medically necessary” and “clinicians who provide abortions are unable to obtain admitting privileges for reasons unrelated to their ability to safely and competently perform abortions.” Justice Breyer cited the ACOG brief twice.

The American Association of Pro-Life Obstetricians and Gynecologists also filed an amicus brief.⁷ The brief was directed solely at arguing that ACOG was not presenting reliable science. It summarized, “The American College of Obstetricians and Gynecologists has always presented itself to the Court as a source of objective medical knowledge. However, when it comes to abortion, the College today is primarily a pro-abortion political advocacy organization.” That brief concluded that the “Court should read ACOG’s amicus brief not as an authoritative recitation of settled science, but as a partisan advocacy paper on behalf of a mere subset of American obstetricians and gynecologists.” 

The Association of American Physicians and Surgeons (which should not be confused with the “National Board of Physicians and Surgeons”) also filed an amicus brief. The brief argued, “Abortion, like other outpatient surgical procedures, sometimes results in patient hospitalization. Requiring abortion providers to maintain admitting privileges will improve communication between physicians in the transfer of patients to the hospital and allow them to participate in the care of their patients while in the hospital, in line with their ethical duty to ensure their patients’ continuity of care.”⁸

Continue to: Ultrasonography requirement for abortion...

In another abortion case, the Court was asked to review a Kentucky abortion statute requiring that an ultrasound image be shown to the woman as part of informed consent for an abortion.⁹ ACOG filed an amicus brief in favor of a review, but the Court declined to hear the case.^10,11 

Contraception considerations

The Affordable Care Act (ACA) has an ambiguous provision regarding no-cost “preventive care and screenings” for women. The ACA does not, however, specify contraceptive coverage.¹² Several departments and the Health Resources and Services Administration (collectively referred to as “HRSA”) interpreted the provision to include contraception, but from the start there were religious objections. HRSA eventually provided an exemption regarding contraception for employers (nonprofits and for-profits with no publicly traded components) that had “sincerely held moral” objections to providing forms of contraceptive coverage. That regulation was again before the Court this term in Little Sisters of the Poor Saints Peter and Paul Home v Pennsylvania.¹³ 

In a 7-2 decision, the Court held that the ACA gave HRSA authority to adopt regulations related to the undefined term “preventive care.” Therefore, it found that HRSA could exempt those with religious objections from participation in providing contraceptive coverage. ACOG and other medical groups filed an amicus brief arguing that contraception is an essential preventive service. “Contraception not only helps to prevent unintended pregnancy, but also helps to protect the health and well-being of women and their children.”¹⁴ It was cited only by Justice Ginsburg in her dissent.¹⁵ 

Deferred Action for Childhood Arrivals (DACA)

The AAMC, ACOG, AMA, and many other organizations filed an amicus brief¹⁶ in Department of Homeland Security v Regents of University of California.¹⁷ The case raised the question of whether a decision to end the DACA program followed the appropriate administrative procedures. In 2012, the Obama administration issued a “memorandum” establishing DACA (without congressional approval or formal rulemaking). A lower court decision barring implementation of DACA was upheld by the Supreme Court in 2016 on a 4-4 vote.¹⁸ In 2017, the Trump administration moved to end DACA. 

In a 5-4 decision, the Court held that the explanation for ending DACA was inadequate, and violated the Administrative Procedures Act, so DACA could continue until the administration redid the repeal, following the proper procedures. The decision of the Court dealt solely with the process by which the rescission took place—there was general agreement that the administration had the right to rescind it if the procedure (with legitimate reasons) was proper.

The brief for the medical groups argued that the failure of the regulation to consider “reliance interests” would have especially difficult consequences in the medical fields. It noted, “At this moment, an estimated 27,000 health care workers and support staff depend on DACA for their authorization to work in the United States. Among those 27,000 are nurses, dentists, pharmacists, physician assistants, home health aides, technicians, and others. The number also includes nearly 200 medical students, medical residents, and physicians who depend on DACA for their eligibility to practice medicine.”¹⁶ The brief was not cited by the Court, but the reliance interest the brief spoke about was an important part of the case.

Continue to: Employment discrimination against gay and transgender employees...

Federal law (“Title VII”) makes it illegal for an employer to “discriminate against any individual because of race, color, religion, sex, or national origin.”¹⁹ The question this term was whether discrimination based on sexual orientation or sexual identity is within the statute’s meaning of “sex.” By a 6-3 majority, the Court held that Title VII applies both to orientation and identity. (This was an interpretation of the statute, not a broad constitutional ruling.)

The majority reasoned that “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex. Consider, for example, an employer with 2 employees, both of whom are attracted to men.” If the employer fires the gay employee, “the employer discriminates against him for traits or actions it tolerates in his female colleague.”²⁰ 

AMA and a number of other medical organizations filed an amicus brief in the case.²¹ The core of the argument of the brief was, “Employment discrimination against transgender people frustrates the treatment of gender dysphoria by preventing transgender individuals from living openly in accordance with their true gender identity and impeding access to needed medical care. Experiencing discrimination in one of the most important aspects of adult life—employment—makes it nearly impossible to live in full congruence with one’s gender identity. The fear of facing such discrimination alone can prompt transgender individuals to hide their gender identity, directly thwarting the goal of social transition…. Lack of treatment, in turn, increases the rate of negative mental health outcomes, substance abuse, and suicide.” The brief was not cited in the opinions in the case.

This decision is likely to have great impact on many aspects of American life. In the employment area, it is now a matter of course that employers may not discriminate based on orientation or identity in any employment decisions including hiring, firing, compensation, fringe benefits, etc. Harassment based on identity or orientation may similarly be an employment law violation. The decision also likely means that giving employment preferences to gay employees would now be as illegal as would be giving preferences to straight employees. (Limited exceptions, notably to some religious organization employees, are not included in anti-discrimination laws.)²² 

The importance of the decision goes well beyond employment, however. More than 100 federal statutes are in place that prohibit “discrimination because of sex.” It is now likely that these statutes will be interpreted as prohibiting discrimination related to sexual orientation and identification. 

Additional cases of interest 

HIV/AIDS International Program

A major US program fighting HIV/AIDS worldwide—the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (aka the Leadership Act)—has provided billions of dollars to agencies abroad.²³ Nongovernmental organizations (NGOs) receiving funds under the program must agree to have a “policy explicitly opposing prostitution and sex trafficking” (known as the “Policy Requirement”). Some grant recipients in foreign countries, generally affiliates of US NGOs, do not want to have such a policy and challenged the policy requirement as a violation of First Amendment right of free speech. The Court held that it is a well-settled principle that “foreign citizens outside US territory do not possess rights under the US Constitution.”²⁴ Nor do organizations become entitled to such rights as a result of an affiliation with US organizations. This decision means that foreign organizations are free not to have the required policies, but they will be ineligible for funds under the Leadership Act. 

Continue to: ACA government debts edition...

The ACA was before the Court, yet again. To encourage private insurers to participate in online health insurance exchanges, the ACA provided that the federal government would share in insurance company losses for 3 years.²⁵ The Act, however, did not appropriate any money for these “risk corridors,” and insurance companies  lost $12 billion. 

Congress (after the 2010 election) prohibited any appropriated funds from being used to pay insurance companies for their risk corridor losses. Four insurance companies sued the United States, seeking reimbursements for their losses. This term the Court held that the government must pay for their losses under the ACA.²⁶ The Court said that Congress could have expressly repealed the risk corridor obligation (in the appropriation bill), but instead had only prohibited the expenditure of the money, which the Court said did not amount to an implied repeal of the obligation. We will see that ACA will be back before the Court again next term in California v Texas (discussed below).

Child custody and international abduction

The Hague Convention on the Civil Aspects of International Child Abduction (to which the United States is a party) provides that the courts of the country where the child has “habitual residence” have jurisdiction to decide custody.²⁷ If a parent takes the child to another country, that country is obligated to return the child to the country of “habitual residence.” 

This term the Court was called upon to define “habitual residence.” The Court held that determining habitual residence depends on the “totality of the circumstances,” and that “locating a child’s home is a fact-driven inquiry,” and that “courts must be sensitive to the unique circumstances of the case and informed by common sense.”²⁸ An exception to the Convention’s obligation to return a child to the country of habitual residence is where “there is a grave risk that [the] return would expose the child to physical or psychological harm or otherwise place the child in an intolerable situation.”²⁹ Who the parent is can affect many aspects of legal authority over the child, including consent to medical care, and the right to receive information concerning care. 

Analysis of the term

The term began October 7, 2019, and adjourned July 9, 2020, somewhat later than usual because of coronavirus disease 2019 (COVID-19). During the term, the Court decided 60 cases, including 53 “signed” merit opinions after oral argument—the lowest number of decided cases in many years.30 Of those 60 cases, 22 (35%) were unanimous, and 13 (22%) resulted in a 5-4 split.³⁰ Ten-year averages are 48% unanimous and 20% with 5-4 decisions.³⁰

Chief Justice Roberts was the central focus of the term. He presided over the impeachment trial of President Trump in the Senate early in the term. He also presided over the Court’s accommodations of the COVID-19 pandemic. He is the “median,” or “swing,” justice. He was in the majority in 12 of the 13 cases with 5-4 decisions.³⁰ He was in the majority in 97% of all cases and in 95% of “divided cases”—the highest of any of the justices this term.³⁰ In some of the most critical decisions, Chief Justice Roberts sided with the “liberal” wing, including on cases concerning abortion, gay and transgender employment, DACA, and 2 Presidential subpoena cases. More often (in 9 of the 5-4 decisions), however, he sided with the more conservative justices.³⁰ Justice Kavanaugh agreed with Chief Justice Roberts most often (in 93% of all cases).³⁰ Among the others, these justices agreed with each other 90% or more of the time: Justices Ginsburg and Breyer (93%), Justices Alito and Thomas (92%), and Justices Breyer and Kagan (90%).³⁰

Continue to: COVID-19 and the Court...

Some of the biggest news of the term came not from the law, but from medicine in the form of  COVID-19. The Court was in the process of preparing a final period of important arguments when, on March 16, it announced that it was postponing further arguments. The Court rescheduled 10 oral arguments that were held by telephone (other cases were held over to the next term). The phone arguments, during the first 2 weeks of May, necessitated a change in format. Each justice was called on (in order of seniority) by the Chief Justice to ask questions. This was in contrast to the free-for-all questions that usually characterize in-person arguments. These arguments were broadcast live—something that had never been done before. Public access was, on balance, a good thing. There were a couple failures to unmute, and there was “the flush heard round the world” in the middle of one argument, but otherwise the arguments went off with few hitches.³¹

Looking ahead

By the end of the term, no justice had announced an intention to retire from the Court. On September 18, however, Justice Ruth Bader Ginsburg passed away. In 2009, she had been diagnosed with early-stage pancreatic cancer. This term she had been hospitalized twice, and at the end of the term, she announced a recurrence of pancreatic cancer, which was being treated with chemotherapy. See “RBG: The woman, the legacy” for a tribute to this remarkable woman, lawyer, and justice.

Justice Ginsburg’s death, occurring in the middle of a presidential campaign, ignited a political firestorm concerning her successor. The outcome of selecting and confirming her successor and the political fallout were not immediately apparent. Justice Ginsburg was confirmed just 7 weeks after her nomination by President Clinton, by a vote of 96-3. But those days of Senate consensus are not the current norm.

The next term (called the “October 2020 Term”) will begin on October 5, 2020. The Court will begin with 8 justices and, depending on the nomination process, may operate with 8 justices for some time. When there is a “tie” vote in the Court, the lower court decision is upheld. The Court has been short-handed several times in the past and, with few exceptions, has managed the cases successfully.

The Court has announced that initial arguments will be telephonic. It already has taken a number of cases. The constitutionality of the individual mandate (coverage) in the ACA will once again be before the Court, and that already has produced a flood of amicus briefs from health-related organizations.³² Among other upcoming issues are cases related to state regulation of pharmacy benefit managers, gay rights and foster care, sentencing of juveniles to life in prison without the possibility of parole, a face-off between Google and Oracle on software copyrights, and arbitration. In addition, some of the issues we saw this term will reappear, with more on robocalls, religious freedom and Catholic charities, and immigration and removal cases.
 

The 2019-2020 term of the US Supreme Court was remarkable by any standard. An extraordinary number of important cases made it “a buffet of blockbusters.”¹ 

We look first at several cases that will be of particular interest to ObGyns. Then we look briefly at a number of other important cases that affect the medical profession as a whole and the direction of the country (see “Other significant US Supreme Court decisions”), and finally we conclude with an analysis of this term and a forecast for the next. 

We chose cases in which specialty organizations, such as the American College of Obstetricians and Gynecologists (ACOG), or organized medicine (the American Medical Association [AMA], the Association of American Medical Colleges [AAMC], or the American Hospital Association [AHA]), took a special interest by filing “amicus curiae” (friend of the court) briefs with the Supreme Court. These briefs are filed by an organization or person who is not a party to the case but who may have important information to convey to the Court. Because these briefs represent a significant commitment of money, time, and effort, they are usually not undertaken lightly. 

Decisions concerning abortion

June v Russo

Decided June 29, 2020, June v Russo involved a Louisiana statute that required abortion providers have “active admitting privileges at a hospital” within 30 miles of where the abortion is performed.² The Court decided a case in 2016 (from Texas) that involved almost the same statutory provision, so it might seem like an easy ruling.³ But Justice Kennedy (the deciding vote in 2016) has been replaced by Justice Gorsuch, so the outcome was uncertain. It was a difficult case, with a total of 5 opinions covering 138 pages and a “surprise” from the Chief Justice. 

The Court, in a 5-4 decision, struck down the Louisiana law, but there was no majority opinion. Four justices in the plurality emphasized that the Louisiana law (like the Texas law) substantially burdened the right to abortion without any corresponding benefit to the health of the women seeking abortions. (Under earlier Court precedents, “undue burdens” on abortion are unconstitutional.⁴) Justice Breyer noted that the state could not present even one example in which a woman would have had better treatment if her doctor had admitting privileges. For a variety of reasons, admitting privileges were cumbersome for abortion providers to obtain; therefore, enforcing the law had little or no benefit, but significant risk of reduced availability of abortion services.

In June v Russo, Chief Justice Roberts literally became the “swing vote”—the fifth vote to strike down the Louisiana law. In 2016, he had voted the other way—to uphold essentially the same law (in Texas) that he struck down here. He attributed his switch to precedent (the general obligation of courts to follow prior decisions). He disagreed with the earlier decision, but felt bound by it. 

This should be the end of the abortion provider “hospital privileges requirements” that a number of states have passed. States seeking to nibble away at abortion rights will undoubtedly look elsewhere. Beyond that, it is difficult, from this case, to discern the future of abortion rights. 

ACOG was the lead in amicus briefs urging the Court to strike down the Louisiana law. ACOG (with others) was one of only a handful of organizations filing a brief urging the Court to agree to hear the case.⁵ When the Court did agree to hear the case (“granted certiorari”), ACOG and a number of other medical organizations filed a formal amicus brief on the merits of the case.⁶ The brief made 2 arguments: First, that this case was essentially decided in Whole Woman’s Health in 2016 (the Texas case) and, second, that “an admitting privileges requirement is not medically necessary” and “clinicians who provide abortions are unable to obtain admitting privileges for reasons unrelated to their ability to safely and competently perform abortions.” Justice Breyer cited the ACOG brief twice.

The American Association of Pro-Life Obstetricians and Gynecologists also filed an amicus brief.⁷ The brief was directed solely at arguing that ACOG was not presenting reliable science. It summarized, “The American College of Obstetricians and Gynecologists has always presented itself to the Court as a source of objective medical knowledge. However, when it comes to abortion, the College today is primarily a pro-abortion political advocacy organization.” That brief concluded that the “Court should read ACOG’s amicus brief not as an authoritative recitation of settled science, but as a partisan advocacy paper on behalf of a mere subset of American obstetricians and gynecologists.” 

The Association of American Physicians and Surgeons (which should not be confused with the “National Board of Physicians and Surgeons”) also filed an amicus brief. The brief argued, “Abortion, like other outpatient surgical procedures, sometimes results in patient hospitalization. Requiring abortion providers to maintain admitting privileges will improve communication between physicians in the transfer of patients to the hospital and allow them to participate in the care of their patients while in the hospital, in line with their ethical duty to ensure their patients’ continuity of care.”⁸

Continue to: Ultrasonography requirement for abortion...

In another abortion case, the Court was asked to review a Kentucky abortion statute requiring that an ultrasound image be shown to the woman as part of informed consent for an abortion.⁹ ACOG filed an amicus brief in favor of a review, but the Court declined to hear the case.^10,11 

Contraception considerations

The Affordable Care Act (ACA) has an ambiguous provision regarding no-cost “preventive care and screenings” for women. The ACA does not, however, specify contraceptive coverage.¹² Several departments and the Health Resources and Services Administration (collectively referred to as “HRSA”) interpreted the provision to include contraception, but from the start there were religious objections. HRSA eventually provided an exemption regarding contraception for employers (nonprofits and for-profits with no publicly traded components) that had “sincerely held moral” objections to providing forms of contraceptive coverage. That regulation was again before the Court this term in Little Sisters of the Poor Saints Peter and Paul Home v Pennsylvania.¹³ 

In a 7-2 decision, the Court held that the ACA gave HRSA authority to adopt regulations related to the undefined term “preventive care.” Therefore, it found that HRSA could exempt those with religious objections from participation in providing contraceptive coverage. ACOG and other medical groups filed an amicus brief arguing that contraception is an essential preventive service. “Contraception not only helps to prevent unintended pregnancy, but also helps to protect the health and well-being of women and their children.”¹⁴ It was cited only by Justice Ginsburg in her dissent.¹⁵ 

Deferred Action for Childhood Arrivals (DACA)

The AAMC, ACOG, AMA, and many other organizations filed an amicus brief¹⁶ in Department of Homeland Security v Regents of University of California.¹⁷ The case raised the question of whether a decision to end the DACA program followed the appropriate administrative procedures. In 2012, the Obama administration issued a “memorandum” establishing DACA (without congressional approval or formal rulemaking). A lower court decision barring implementation of DACA was upheld by the Supreme Court in 2016 on a 4-4 vote.¹⁸ In 2017, the Trump administration moved to end DACA. 

In a 5-4 decision, the Court held that the explanation for ending DACA was inadequate, and violated the Administrative Procedures Act, so DACA could continue until the administration redid the repeal, following the proper procedures. The decision of the Court dealt solely with the process by which the rescission took place—there was general agreement that the administration had the right to rescind it if the procedure (with legitimate reasons) was proper.

The brief for the medical groups argued that the failure of the regulation to consider “reliance interests” would have especially difficult consequences in the medical fields. It noted, “At this moment, an estimated 27,000 health care workers and support staff depend on DACA for their authorization to work in the United States. Among those 27,000 are nurses, dentists, pharmacists, physician assistants, home health aides, technicians, and others. The number also includes nearly 200 medical students, medical residents, and physicians who depend on DACA for their eligibility to practice medicine.”¹⁶ The brief was not cited by the Court, but the reliance interest the brief spoke about was an important part of the case.

Continue to: Employment discrimination against gay and transgender employees...

Federal law (“Title VII”) makes it illegal for an employer to “discriminate against any individual because of race, color, religion, sex, or national origin.”¹⁹ The question this term was whether discrimination based on sexual orientation or sexual identity is within the statute’s meaning of “sex.” By a 6-3 majority, the Court held that Title VII applies both to orientation and identity. (This was an interpretation of the statute, not a broad constitutional ruling.)

The majority reasoned that “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex. Consider, for example, an employer with 2 employees, both of whom are attracted to men.” If the employer fires the gay employee, “the employer discriminates against him for traits or actions it tolerates in his female colleague.”²⁰ 

AMA and a number of other medical organizations filed an amicus brief in the case.²¹ The core of the argument of the brief was, “Employment discrimination against transgender people frustrates the treatment of gender dysphoria by preventing transgender individuals from living openly in accordance with their true gender identity and impeding access to needed medical care. Experiencing discrimination in one of the most important aspects of adult life—employment—makes it nearly impossible to live in full congruence with one’s gender identity. The fear of facing such discrimination alone can prompt transgender individuals to hide their gender identity, directly thwarting the goal of social transition…. Lack of treatment, in turn, increases the rate of negative mental health outcomes, substance abuse, and suicide.” The brief was not cited in the opinions in the case.

This decision is likely to have great impact on many aspects of American life. In the employment area, it is now a matter of course that employers may not discriminate based on orientation or identity in any employment decisions including hiring, firing, compensation, fringe benefits, etc. Harassment based on identity or orientation may similarly be an employment law violation. The decision also likely means that giving employment preferences to gay employees would now be as illegal as would be giving preferences to straight employees. (Limited exceptions, notably to some religious organization employees, are not included in anti-discrimination laws.)²² 

The importance of the decision goes well beyond employment, however. More than 100 federal statutes are in place that prohibit “discrimination because of sex.” It is now likely that these statutes will be interpreted as prohibiting discrimination related to sexual orientation and identification. 

Additional cases of interest 

HIV/AIDS International Program

A major US program fighting HIV/AIDS worldwide—the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (aka the Leadership Act)—has provided billions of dollars to agencies abroad.²³ Nongovernmental organizations (NGOs) receiving funds under the program must agree to have a “policy explicitly opposing prostitution and sex trafficking” (known as the “Policy Requirement”). Some grant recipients in foreign countries, generally affiliates of US NGOs, do not want to have such a policy and challenged the policy requirement as a violation of First Amendment right of free speech. The Court held that it is a well-settled principle that “foreign citizens outside US territory do not possess rights under the US Constitution.”²⁴ Nor do organizations become entitled to such rights as a result of an affiliation with US organizations. This decision means that foreign organizations are free not to have the required policies, but they will be ineligible for funds under the Leadership Act. 

Continue to: ACA government debts edition...

The ACA was before the Court, yet again. To encourage private insurers to participate in online health insurance exchanges, the ACA provided that the federal government would share in insurance company losses for 3 years.²⁵ The Act, however, did not appropriate any money for these “risk corridors,” and insurance companies  lost $12 billion. 

Congress (after the 2010 election) prohibited any appropriated funds from being used to pay insurance companies for their risk corridor losses. Four insurance companies sued the United States, seeking reimbursements for their losses. This term the Court held that the government must pay for their losses under the ACA.²⁶ The Court said that Congress could have expressly repealed the risk corridor obligation (in the appropriation bill), but instead had only prohibited the expenditure of the money, which the Court said did not amount to an implied repeal of the obligation. We will see that ACA will be back before the Court again next term in California v Texas (discussed below).

Child custody and international abduction

The Hague Convention on the Civil Aspects of International Child Abduction (to which the United States is a party) provides that the courts of the country where the child has “habitual residence” have jurisdiction to decide custody.²⁷ If a parent takes the child to another country, that country is obligated to return the child to the country of “habitual residence.” 

This term the Court was called upon to define “habitual residence.” The Court held that determining habitual residence depends on the “totality of the circumstances,” and that “locating a child’s home is a fact-driven inquiry,” and that “courts must be sensitive to the unique circumstances of the case and informed by common sense.”²⁸ An exception to the Convention’s obligation to return a child to the country of habitual residence is where “there is a grave risk that [the] return would expose the child to physical or psychological harm or otherwise place the child in an intolerable situation.”²⁹ Who the parent is can affect many aspects of legal authority over the child, including consent to medical care, and the right to receive information concerning care. 

Analysis of the term

The term began October 7, 2019, and adjourned July 9, 2020, somewhat later than usual because of coronavirus disease 2019 (COVID-19). During the term, the Court decided 60 cases, including 53 “signed” merit opinions after oral argument—the lowest number of decided cases in many years.30 Of those 60 cases, 22 (35%) were unanimous, and 13 (22%) resulted in a 5-4 split.³⁰ Ten-year averages are 48% unanimous and 20% with 5-4 decisions.³⁰

Chief Justice Roberts was the central focus of the term. He presided over the impeachment trial of President Trump in the Senate early in the term. He also presided over the Court’s accommodations of the COVID-19 pandemic. He is the “median,” or “swing,” justice. He was in the majority in 12 of the 13 cases with 5-4 decisions.³⁰ He was in the majority in 97% of all cases and in 95% of “divided cases”—the highest of any of the justices this term.³⁰ In some of the most critical decisions, Chief Justice Roberts sided with the “liberal” wing, including on cases concerning abortion, gay and transgender employment, DACA, and 2 Presidential subpoena cases. More often (in 9 of the 5-4 decisions), however, he sided with the more conservative justices.³⁰ Justice Kavanaugh agreed with Chief Justice Roberts most often (in 93% of all cases).³⁰ Among the others, these justices agreed with each other 90% or more of the time: Justices Ginsburg and Breyer (93%), Justices Alito and Thomas (92%), and Justices Breyer and Kagan (90%).³⁰

Continue to: COVID-19 and the Court...

Some of the biggest news of the term came not from the law, but from medicine in the form of  COVID-19. The Court was in the process of preparing a final period of important arguments when, on March 16, it announced that it was postponing further arguments. The Court rescheduled 10 oral arguments that were held by telephone (other cases were held over to the next term). The phone arguments, during the first 2 weeks of May, necessitated a change in format. Each justice was called on (in order of seniority) by the Chief Justice to ask questions. This was in contrast to the free-for-all questions that usually characterize in-person arguments. These arguments were broadcast live—something that had never been done before. Public access was, on balance, a good thing. There were a couple failures to unmute, and there was “the flush heard round the world” in the middle of one argument, but otherwise the arguments went off with few hitches.³¹

Looking ahead

By the end of the term, no justice had announced an intention to retire from the Court. On September 18, however, Justice Ruth Bader Ginsburg passed away. In 2009, she had been diagnosed with early-stage pancreatic cancer. This term she had been hospitalized twice, and at the end of the term, she announced a recurrence of pancreatic cancer, which was being treated with chemotherapy. See “RBG: The woman, the legacy” for a tribute to this remarkable woman, lawyer, and justice.

Justice Ginsburg’s death, occurring in the middle of a presidential campaign, ignited a political firestorm concerning her successor. The outcome of selecting and confirming her successor and the political fallout were not immediately apparent. Justice Ginsburg was confirmed just 7 weeks after her nomination by President Clinton, by a vote of 96-3. But those days of Senate consensus are not the current norm.

The next term (called the “October 2020 Term”) will begin on October 5, 2020. The Court will begin with 8 justices and, depending on the nomination process, may operate with 8 justices for some time. When there is a “tie” vote in the Court, the lower court decision is upheld. The Court has been short-handed several times in the past and, with few exceptions, has managed the cases successfully.

The Court has announced that initial arguments will be telephonic. It already has taken a number of cases. The constitutionality of the individual mandate (coverage) in the ACA will once again be before the Court, and that already has produced a flood of amicus briefs from health-related organizations.³² Among other upcoming issues are cases related to state regulation of pharmacy benefit managers, gay rights and foster care, sentencing of juveniles to life in prison without the possibility of parole, a face-off between Google and Oracle on software copyrights, and arbitration. In addition, some of the issues we saw this term will reappear, with more on robocalls, religious freedom and Catholic charities, and immigration and removal cases.
 

You’ve been struggling with what to do for a patient who has a significant mental health problem and really would love to have some help. You’re willing to fill out the requisite referral forms and wait your turn for what seems like an excruciating amount of time. But how do you ensure that you, your patient, and the family get the most out of the consultative experience so that everyone’s questions are answered and ongoing care, if needed, can continue?

sturti/Getty Images

To be fair, most of the burden of doing a good psychiatric or mental health consultation rests on the consultant, not the person making the request. It is their job to do a thorough evaluation and to identify any additional pieces of information that may be missing before a strong conclusion can be made. That said, however, this is the real world where everyone is busy and few have the time to track down every loose end that may exist regarding a patient’s history. Like most scientific investigations, the quality of what comes out of a psychiatric consultation depends a lot on what goes into them.

To that end, here are some recommendations for how to increase the chance that the outcome of your consultation with a child psychiatrist or other mental health professional will be maximally helpful for everyone involved. These tips are based on having been on the receiving end of psychiatric consultations for almost 2 decades and having worked closely with primary care clinicians in a number of different capacities.

The first question to ask yourself, and this may be the most important one of all, is whether or not you really need an actual psychiatrist at all at this stage versus another type of mental health professional. Physicians often are most comfortable dealing with other physicians. If a pediatrician has a question about a patient’s heart, it’s logical to consult a cardiologist. Thus if there’s a question about mental health, the knee-jerk reaction is to consult a psychiatrist. While understandable, looking first to a psychiatrist to help with a patient’s mental health struggles often is not the best move. Psychiatrists make up only one small part of all mental health professionals that also include psychologists, counselors, and clinical social workers, among others. The availability of child and adolescent psychiatrists can been exceedingly sparse while other types of mental health professionals generally are much more available. Moreover, these other types of mental health professionals also can do a great job at assessment and treatment. It is true that most can’t prescribe medication, but best practice recommendations for most of the common mental health diagnoses in youth (anxiety, depression, obsessive compulsive disorder, etc.) explicitly outline that nonpharmacologic treatments should be used first. It breaks my heart every time I do a consult for a family who has waited 6 months only to have me recommend a good therapist they could have seen right off in a week.

Get to know the mental health resources of your community beyond the small number of psychiatrists who might be there. And if you aren’t sure whether or not a referral might best go first to a mental health professional who is not a psychiatrist, just ask. That quick phone call or email might save the family a needless delay in treatment and a lot of aggravation for you.

If you are confident that it is a child & adolescent psychiatrist you want your patient to see, here are some things that will help you get the most out of that consultation and help you avoid the disappointment (for both you and the family) of an evaluation that completely misses the mark.
 

Select the best site (if you have an option)

Broadly speaking, psychiatrists often can be found in three main areas: academic clinics, private practice, and community mental health centers. While of course there is huge variation of clinicians at each of the sites, some generalizations regarding typical advantages and disadvantages of each setting are probably fair.

Academic settings often have psychiatrists who are local or even national experts on particular topics and can be good places to get evaluations for patients with complicated histories. At the same time, however, these settings typically rely on trainees to do much of the actual work. Many of the residents and fellows are excellent, but they turn over quickly because of graduation and finishing rotations, which can force patients to get to know a lot of different people. Academic centers also can be quite a distance from a family’s home, which often makes follow-up care a challenge (especially when we go back to more in-person visits).

Private practice psychiatrists can provide a more local option and can give families access to experienced clinicians, but many of these practices (especially the ones that take insurance) have practice models that involve seeing a lot of patients for short amounts of time and with less coordination with other types of services.

Finally, psychiatrists working at community mental health centers often work in teams that can help families get access to a lot of useful ancillary services (case management, home supports, etc.) but are part of a public mental health system that sadly is all too often overstretched and underfunded.

If you have choices for where to go for psychiatric services, keeping these things in mind can help you find the best fit for families.
 

Provide a medication history

While I’m not a big fan of the “what medicine do I try next?” consultation, don’t rely on families to provide this information accurately. Medications are confusing, and I can’t tell you how many times I’ve heard: “I tried the little blue pill and then the big white capsule.” Nobody feels good if the end result of a long consultative process includes a recommendation for a medication that the patient has already tried and failed. Some EMRs now have this information in a way that can be more easily packaged and shared.

State what you are looking for

If you really want the psychiatrist to take over the care of the patient, are just looking for some guidance for what to do next, or are seeking a second opinion for a patient that already works with a psychiatrist, stating so specifically can help tailor the consultation to best address the situation.

Send along past evaluations

Many patients have accumulated detailed psychological or educational evaluations over time that can include some really important information like cognitive profiles, other diagnostic impressions, and past treatment recommendations that may or may not have been implemented. Having these available to the consulting psychiatrist (of course parents need to give permission to send these along) can help the consultant avoid asking redundant questions or recommend things that already have been tried.

Rule outs of medical causes

There are a lot of psychiatric symptoms that can be caused by nonpsychiatric causes. Sometimes, there can be an assumption on the part of the psychiatrist that the pediatrician already has evaluated for these possibilities while the pediatrician assumes that the psychiatrist will work those up if needed. This is how the care of some patients fall through the cracks, and how those unflattering stories of how patients were forced to live with undiagnosed ailments (seizures, encephalopathy, Lyme disease, etc.) for years are generated. Being clear what work-up and tests already have been done to look for other causes can help everyone involved decide what should be done next and who should do it.

Yes, it is true that most of the recommendations specified here involve more work that the quick “behavioral problems: eval and treat” note that may be tempting to write when consulting with a mental health professional, but they will help avoid a lot of headaches for you down the road and, most importantly, get patients and families the timely and comprehensive care they deserve.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. Dr. Rettew said he had no relevant financial disclosures. Email Dr. Rettew at [email protected].

You’ve been struggling with what to do for a patient who has a significant mental health problem and really would love to have some help. You’re willing to fill out the requisite referral forms and wait your turn for what seems like an excruciating amount of time. But how do you ensure that you, your patient, and the family get the most out of the consultative experience so that everyone’s questions are answered and ongoing care, if needed, can continue?

sturti/Getty Images

To be fair, most of the burden of doing a good psychiatric or mental health consultation rests on the consultant, not the person making the request. It is their job to do a thorough evaluation and to identify any additional pieces of information that may be missing before a strong conclusion can be made. That said, however, this is the real world where everyone is busy and few have the time to track down every loose end that may exist regarding a patient’s history. Like most scientific investigations, the quality of what comes out of a psychiatric consultation depends a lot on what goes into them.

To that end, here are some recommendations for how to increase the chance that the outcome of your consultation with a child psychiatrist or other mental health professional will be maximally helpful for everyone involved. These tips are based on having been on the receiving end of psychiatric consultations for almost 2 decades and having worked closely with primary care clinicians in a number of different capacities.

The first question to ask yourself, and this may be the most important one of all, is whether or not you really need an actual psychiatrist at all at this stage versus another type of mental health professional. Physicians often are most comfortable dealing with other physicians. If a pediatrician has a question about a patient’s heart, it’s logical to consult a cardiologist. Thus if there’s a question about mental health, the knee-jerk reaction is to consult a psychiatrist. While understandable, looking first to a psychiatrist to help with a patient’s mental health struggles often is not the best move. Psychiatrists make up only one small part of all mental health professionals that also include psychologists, counselors, and clinical social workers, among others. The availability of child and adolescent psychiatrists can been exceedingly sparse while other types of mental health professionals generally are much more available. Moreover, these other types of mental health professionals also can do a great job at assessment and treatment. It is true that most can’t prescribe medication, but best practice recommendations for most of the common mental health diagnoses in youth (anxiety, depression, obsessive compulsive disorder, etc.) explicitly outline that nonpharmacologic treatments should be used first. It breaks my heart every time I do a consult for a family who has waited 6 months only to have me recommend a good therapist they could have seen right off in a week.

Get to know the mental health resources of your community beyond the small number of psychiatrists who might be there. And if you aren’t sure whether or not a referral might best go first to a mental health professional who is not a psychiatrist, just ask. That quick phone call or email might save the family a needless delay in treatment and a lot of aggravation for you.

If you are confident that it is a child & adolescent psychiatrist you want your patient to see, here are some things that will help you get the most out of that consultation and help you avoid the disappointment (for both you and the family) of an evaluation that completely misses the mark.
 

Select the best site (if you have an option)

Broadly speaking, psychiatrists often can be found in three main areas: academic clinics, private practice, and community mental health centers. While of course there is huge variation of clinicians at each of the sites, some generalizations regarding typical advantages and disadvantages of each setting are probably fair.

Academic settings often have psychiatrists who are local or even national experts on particular topics and can be good places to get evaluations for patients with complicated histories. At the same time, however, these settings typically rely on trainees to do much of the actual work. Many of the residents and fellows are excellent, but they turn over quickly because of graduation and finishing rotations, which can force patients to get to know a lot of different people. Academic centers also can be quite a distance from a family’s home, which often makes follow-up care a challenge (especially when we go back to more in-person visits).

Private practice psychiatrists can provide a more local option and can give families access to experienced clinicians, but many of these practices (especially the ones that take insurance) have practice models that involve seeing a lot of patients for short amounts of time and with less coordination with other types of services.

Finally, psychiatrists working at community mental health centers often work in teams that can help families get access to a lot of useful ancillary services (case management, home supports, etc.) but are part of a public mental health system that sadly is all too often overstretched and underfunded.

If you have choices for where to go for psychiatric services, keeping these things in mind can help you find the best fit for families.
 

Provide a medication history

While I’m not a big fan of the “what medicine do I try next?” consultation, don’t rely on families to provide this information accurately. Medications are confusing, and I can’t tell you how many times I’ve heard: “I tried the little blue pill and then the big white capsule.” Nobody feels good if the end result of a long consultative process includes a recommendation for a medication that the patient has already tried and failed. Some EMRs now have this information in a way that can be more easily packaged and shared.

State what you are looking for

If you really want the psychiatrist to take over the care of the patient, are just looking for some guidance for what to do next, or are seeking a second opinion for a patient that already works with a psychiatrist, stating so specifically can help tailor the consultation to best address the situation.

Send along past evaluations

Many patients have accumulated detailed psychological or educational evaluations over time that can include some really important information like cognitive profiles, other diagnostic impressions, and past treatment recommendations that may or may not have been implemented. Having these available to the consulting psychiatrist (of course parents need to give permission to send these along) can help the consultant avoid asking redundant questions or recommend things that already have been tried.

Rule outs of medical causes

There are a lot of psychiatric symptoms that can be caused by nonpsychiatric causes. Sometimes, there can be an assumption on the part of the psychiatrist that the pediatrician already has evaluated for these possibilities while the pediatrician assumes that the psychiatrist will work those up if needed. This is how the care of some patients fall through the cracks, and how those unflattering stories of how patients were forced to live with undiagnosed ailments (seizures, encephalopathy, Lyme disease, etc.) for years are generated. Being clear what work-up and tests already have been done to look for other causes can help everyone involved decide what should be done next and who should do it.

Yes, it is true that most of the recommendations specified here involve more work that the quick “behavioral problems: eval and treat” note that may be tempting to write when consulting with a mental health professional, but they will help avoid a lot of headaches for you down the road and, most importantly, get patients and families the timely and comprehensive care they deserve.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. Dr. Rettew said he had no relevant financial disclosures. Email Dr. Rettew at [email protected].

You’ve been struggling with what to do for a patient who has a significant mental health problem and really would love to have some help. You’re willing to fill out the requisite referral forms and wait your turn for what seems like an excruciating amount of time. But how do you ensure that you, your patient, and the family get the most out of the consultative experience so that everyone’s questions are answered and ongoing care, if needed, can continue?

sturti/Getty Images

To be fair, most of the burden of doing a good psychiatric or mental health consultation rests on the consultant, not the person making the request. It is their job to do a thorough evaluation and to identify any additional pieces of information that may be missing before a strong conclusion can be made. That said, however, this is the real world where everyone is busy and few have the time to track down every loose end that may exist regarding a patient’s history. Like most scientific investigations, the quality of what comes out of a psychiatric consultation depends a lot on what goes into them.

To that end, here are some recommendations for how to increase the chance that the outcome of your consultation with a child psychiatrist or other mental health professional will be maximally helpful for everyone involved. These tips are based on having been on the receiving end of psychiatric consultations for almost 2 decades and having worked closely with primary care clinicians in a number of different capacities.

The first question to ask yourself, and this may be the most important one of all, is whether or not you really need an actual psychiatrist at all at this stage versus another type of mental health professional. Physicians often are most comfortable dealing with other physicians. If a pediatrician has a question about a patient’s heart, it’s logical to consult a cardiologist. Thus if there’s a question about mental health, the knee-jerk reaction is to consult a psychiatrist. While understandable, looking first to a psychiatrist to help with a patient’s mental health struggles often is not the best move. Psychiatrists make up only one small part of all mental health professionals that also include psychologists, counselors, and clinical social workers, among others. The availability of child and adolescent psychiatrists can been exceedingly sparse while other types of mental health professionals generally are much more available. Moreover, these other types of mental health professionals also can do a great job at assessment and treatment. It is true that most can’t prescribe medication, but best practice recommendations for most of the common mental health diagnoses in youth (anxiety, depression, obsessive compulsive disorder, etc.) explicitly outline that nonpharmacologic treatments should be used first. It breaks my heart every time I do a consult for a family who has waited 6 months only to have me recommend a good therapist they could have seen right off in a week.

Get to know the mental health resources of your community beyond the small number of psychiatrists who might be there. And if you aren’t sure whether or not a referral might best go first to a mental health professional who is not a psychiatrist, just ask. That quick phone call or email might save the family a needless delay in treatment and a lot of aggravation for you.

If you are confident that it is a child & adolescent psychiatrist you want your patient to see, here are some things that will help you get the most out of that consultation and help you avoid the disappointment (for both you and the family) of an evaluation that completely misses the mark.
 

Select the best site (if you have an option)

Broadly speaking, psychiatrists often can be found in three main areas: academic clinics, private practice, and community mental health centers. While of course there is huge variation of clinicians at each of the sites, some generalizations regarding typical advantages and disadvantages of each setting are probably fair.

Academic settings often have psychiatrists who are local or even national experts on particular topics and can be good places to get evaluations for patients with complicated histories. At the same time, however, these settings typically rely on trainees to do much of the actual work. Many of the residents and fellows are excellent, but they turn over quickly because of graduation and finishing rotations, which can force patients to get to know a lot of different people. Academic centers also can be quite a distance from a family’s home, which often makes follow-up care a challenge (especially when we go back to more in-person visits).

Private practice psychiatrists can provide a more local option and can give families access to experienced clinicians, but many of these practices (especially the ones that take insurance) have practice models that involve seeing a lot of patients for short amounts of time and with less coordination with other types of services.

Finally, psychiatrists working at community mental health centers often work in teams that can help families get access to a lot of useful ancillary services (case management, home supports, etc.) but are part of a public mental health system that sadly is all too often overstretched and underfunded.

If you have choices for where to go for psychiatric services, keeping these things in mind can help you find the best fit for families.
 

Provide a medication history

While I’m not a big fan of the “what medicine do I try next?” consultation, don’t rely on families to provide this information accurately. Medications are confusing, and I can’t tell you how many times I’ve heard: “I tried the little blue pill and then the big white capsule.” Nobody feels good if the end result of a long consultative process includes a recommendation for a medication that the patient has already tried and failed. Some EMRs now have this information in a way that can be more easily packaged and shared.

State what you are looking for

If you really want the psychiatrist to take over the care of the patient, are just looking for some guidance for what to do next, or are seeking a second opinion for a patient that already works with a psychiatrist, stating so specifically can help tailor the consultation to best address the situation.

Send along past evaluations

Many patients have accumulated detailed psychological or educational evaluations over time that can include some really important information like cognitive profiles, other diagnostic impressions, and past treatment recommendations that may or may not have been implemented. Having these available to the consulting psychiatrist (of course parents need to give permission to send these along) can help the consultant avoid asking redundant questions or recommend things that already have been tried.

Rule outs of medical causes

There are a lot of psychiatric symptoms that can be caused by nonpsychiatric causes. Sometimes, there can be an assumption on the part of the psychiatrist that the pediatrician already has evaluated for these possibilities while the pediatrician assumes that the psychiatrist will work those up if needed. This is how the care of some patients fall through the cracks, and how those unflattering stories of how patients were forced to live with undiagnosed ailments (seizures, encephalopathy, Lyme disease, etc.) for years are generated. Being clear what work-up and tests already have been done to look for other causes can help everyone involved decide what should be done next and who should do it.

Yes, it is true that most of the recommendations specified here involve more work that the quick “behavioral problems: eval and treat” note that may be tempting to write when consulting with a mental health professional, but they will help avoid a lot of headaches for you down the road and, most importantly, get patients and families the timely and comprehensive care they deserve.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. Dr. Rettew said he had no relevant financial disclosures. Email Dr. Rettew at [email protected].

Several recently approved and late-phase investigational agents may improve care for patients with higher risk myelodysplastic syndrome (MDS) by augmenting hypomethylating agents (HMAs), which are the current standard of care.

“HMA failure remains a challenge, and new approaches, such as ex vivo drug screening, are needed to improve outcomes,” said Brian A. Jonas, MD, PhD, from the University of California, Davis, in an online presentation during the virtual American Society of Hematology (ASH) Meeting on Hematologic Malignancies.

The goal of treatment for patients with higher-risk MDS – defined as a Revised International Prognostic Scoring System (R-IPSS) intermediate, high-risk, or very high–risk category – is to alter as much as possible the natural history of the disease.

Treatment options include monotherapy with HMAs, HMAs in combination with other agents, high-intensity chemotherapy, allogeneic hematopoietic stem cell transplant (allo-HSCT), or a clinical trial, Dr. Jonas said.
 

Improving bioavailability

Although HMAs, either azacitidine or decitabine, remain the standard of care for patients with higher-risk MDS, the oral bioavailability of these agents is limited by the rapid clearance of cytidine deaminase in the gut and liver.

But as Savona and colleagues reported in The Lancet Haematology, the combination of oral decitabine with cedazuridine, a novel cytidine deaminase inhibitor, significantly improved the bioavailability of the HMA, with an efficacy comparable to that of intravenous decitabine. The findings were confirmed by results from the phase 2 ASCERTAIN trial.

The combination (Inqovi) was approved by the US Food and Drug Administration in July 2020 for the treatment of MDS and chronic myelomonocytic leukemia in IPSS intermediate-1 or higher risk categories. The approved dose is 35 mg decitabine and 100 mg cedazuridine in a single oral tablet once daily on days 1 through 5 of each 28-day cycle.
 

New drugs, potential new targets

Another promising approach to improving HMA therapy is the combination of azacitidine and the BCL-2 inhibitor venetoclax (Venclexta).

Results of a phase 1b study of the combination as first-line therapy for patients with higher-risk MDS showed a combined complete response and marrow complete response rate of 77.2%, with estimated 6-month and 12-month survival rates of 100% and 93.8%, respectively, for patients who had a complete response and 85.9% at both 6 and 12 months for patients with a marrow complete response.

“The question is does this challenge the standard of care for higher-risk MDS? I would argue that many are using the regimen since the abstract came out, and I myself consider this regimen for use in select patients with high–blast count MDS who are maybe going to transplant or need to have their disease controlled rapidly,” Dr. Jonas said.

A randomized trial of the combination (NCT04401748) is currently recruiting.
 

Novel checkpoint inhibitor

Another promising combination pairs azacitidine with magrolimab, an experimental immune checkpoint inhibitor that targets CD47, the “don’t eat me” signal that inhibits macrophages from carrying out their crucial phagocytosis role.

As previously reported, magrolimab in combination with rituximab showed good efficacy in patients with relapsed or refractory indolent or aggressive non-Hodgkin lymphomas, and more recently showed promise in combination with azacitidine in a phase 1b study for the treatment of MDS and acute myeloid leukemia (AML).

Among patients with MDS in the trial, the overall response rate was 91% (30 of 33 patients). In all, 14 patients had complete responses, one had a partial response, eight had marrow complete responses, and seven had hematologic improvement.

The tolerability profile was similar to that seen with azacitidine monotherapy, with no significant worsening of cytopenias or infections or autoimmune adverse events. There were no deaths in the first 60 days on therapy, and no treatment discontinuation for drug-related adverse events.

Azacitidine was paired with a different novel agent, APR-246 in a clinical trial testing the combination in patients with TP53 mutant MDS and AML. APR-246 is a novel, first-in-class small molecule that binds covalently to p53, and selectively induces apoptosis in metastatic TP53 cells via thermodynamically stabilizing the p53 protein and shifting equilibrium toward the wild-type conformation.

Among 33 evaluable patients with higher-risk MDS, the combination was associated with an overall response in 29 (81%) including 20 patients (61%) with a complete response. After a median follow-up of 10.8 months, the median duration of response was 7.3 months, and 17 patients went on to allo-HSCT.

The combination of magrolimab and azacitidine has also shown preliminary activity in TP53-mutated MDS, Dr. Jonas noted.
 

HMA-refractory disease

Patients who experience disease progression to AML or to higher-risk MDS; have stable disease but no complete, partial, or marrow responses; or have hematologic improvement after four to six cycles of HMA may have primary resistance to this class of agents. Patients can also have disease that develops resistance to HMAs after an initial response.

“Unfortunately, the prognosis is very dismal for these patients,” with a median overall survival of 5.6 months and 2-year overall survival of just 15%, Dr. Jonas said.

As reported at the 2019 ASH annual meeting, in patients with relapsed/refractory MDS, venetoclax plus azacitidine was associated with a median progression-free survival of 9.1 months versus 3.3 months for venetoclax alone, and a median overall survival for the combination that was not reached, with a 12-month overall survival estimate of 65%. The median overall survival with venetoclax monotherapy was 5.5 months.

Adverse events included cytopenias, gastrointestinal events, and infections in both arms (ASH 2019 Abstract 565).

There are also data to suggest benefits of the isocitrate dehydrogenase inhibitors ivosidenib in patients with HMA-refractory MDS with IDH1 mutations and enasidenib in patients with HMA-refractory MDS with IDH2 mutations, Dr. Jonas said.

Finally, he described a pilot and feasibility study of ex vivo screening of myeloid neoplasms for drug sensitivity conducted at Stanford (Calif.) University. In 21 patients with HMA-refractory MDS, the ex vivo screening system provided results in a clinically actionable time frame comparable to that of a 596-gene panel. The positive predictive value of the screen was 92%, the negative predictive value was 82%, and the accuracy was 85%.

“This looks like a potentially promising approach to offer personalized therapy in patients with MDS,” he said.

No funding source for the presentation was reported. Dr. Jonas disclosed consulting activities for AbbVie, Celgen, GlycoMimetics, Jazz, Takeda, Tolero, and Treadwell; institutional research funding from multiple companies; and discussion of off-label use of various drugs not specifically approved for MDS.

Several recently approved and late-phase investigational agents may improve care for patients with higher risk myelodysplastic syndrome (MDS) by augmenting hypomethylating agents (HMAs), which are the current standard of care.

“HMA failure remains a challenge, and new approaches, such as ex vivo drug screening, are needed to improve outcomes,” said Brian A. Jonas, MD, PhD, from the University of California, Davis, in an online presentation during the virtual American Society of Hematology (ASH) Meeting on Hematologic Malignancies.

The goal of treatment for patients with higher-risk MDS – defined as a Revised International Prognostic Scoring System (R-IPSS) intermediate, high-risk, or very high–risk category – is to alter as much as possible the natural history of the disease.

Treatment options include monotherapy with HMAs, HMAs in combination with other agents, high-intensity chemotherapy, allogeneic hematopoietic stem cell transplant (allo-HSCT), or a clinical trial, Dr. Jonas said.
 

Improving bioavailability

Although HMAs, either azacitidine or decitabine, remain the standard of care for patients with higher-risk MDS, the oral bioavailability of these agents is limited by the rapid clearance of cytidine deaminase in the gut and liver.

But as Savona and colleagues reported in The Lancet Haematology, the combination of oral decitabine with cedazuridine, a novel cytidine deaminase inhibitor, significantly improved the bioavailability of the HMA, with an efficacy comparable to that of intravenous decitabine. The findings were confirmed by results from the phase 2 ASCERTAIN trial.

The combination (Inqovi) was approved by the US Food and Drug Administration in July 2020 for the treatment of MDS and chronic myelomonocytic leukemia in IPSS intermediate-1 or higher risk categories. The approved dose is 35 mg decitabine and 100 mg cedazuridine in a single oral tablet once daily on days 1 through 5 of each 28-day cycle.
 

New drugs, potential new targets

Another promising approach to improving HMA therapy is the combination of azacitidine and the BCL-2 inhibitor venetoclax (Venclexta).

Results of a phase 1b study of the combination as first-line therapy for patients with higher-risk MDS showed a combined complete response and marrow complete response rate of 77.2%, with estimated 6-month and 12-month survival rates of 100% and 93.8%, respectively, for patients who had a complete response and 85.9% at both 6 and 12 months for patients with a marrow complete response.

“The question is does this challenge the standard of care for higher-risk MDS? I would argue that many are using the regimen since the abstract came out, and I myself consider this regimen for use in select patients with high–blast count MDS who are maybe going to transplant or need to have their disease controlled rapidly,” Dr. Jonas said.

A randomized trial of the combination (NCT04401748) is currently recruiting.
 

Novel checkpoint inhibitor

Another promising combination pairs azacitidine with magrolimab, an experimental immune checkpoint inhibitor that targets CD47, the “don’t eat me” signal that inhibits macrophages from carrying out their crucial phagocytosis role.

As previously reported, magrolimab in combination with rituximab showed good efficacy in patients with relapsed or refractory indolent or aggressive non-Hodgkin lymphomas, and more recently showed promise in combination with azacitidine in a phase 1b study for the treatment of MDS and acute myeloid leukemia (AML).

Among patients with MDS in the trial, the overall response rate was 91% (30 of 33 patients). In all, 14 patients had complete responses, one had a partial response, eight had marrow complete responses, and seven had hematologic improvement.

The tolerability profile was similar to that seen with azacitidine monotherapy, with no significant worsening of cytopenias or infections or autoimmune adverse events. There were no deaths in the first 60 days on therapy, and no treatment discontinuation for drug-related adverse events.

Azacitidine was paired with a different novel agent, APR-246 in a clinical trial testing the combination in patients with TP53 mutant MDS and AML. APR-246 is a novel, first-in-class small molecule that binds covalently to p53, and selectively induces apoptosis in metastatic TP53 cells via thermodynamically stabilizing the p53 protein and shifting equilibrium toward the wild-type conformation.

Among 33 evaluable patients with higher-risk MDS, the combination was associated with an overall response in 29 (81%) including 20 patients (61%) with a complete response. After a median follow-up of 10.8 months, the median duration of response was 7.3 months, and 17 patients went on to allo-HSCT.

The combination of magrolimab and azacitidine has also shown preliminary activity in TP53-mutated MDS, Dr. Jonas noted.
 

HMA-refractory disease

Patients who experience disease progression to AML or to higher-risk MDS; have stable disease but no complete, partial, or marrow responses; or have hematologic improvement after four to six cycles of HMA may have primary resistance to this class of agents. Patients can also have disease that develops resistance to HMAs after an initial response.

“Unfortunately, the prognosis is very dismal for these patients,” with a median overall survival of 5.6 months and 2-year overall survival of just 15%, Dr. Jonas said.

As reported at the 2019 ASH annual meeting, in patients with relapsed/refractory MDS, venetoclax plus azacitidine was associated with a median progression-free survival of 9.1 months versus 3.3 months for venetoclax alone, and a median overall survival for the combination that was not reached, with a 12-month overall survival estimate of 65%. The median overall survival with venetoclax monotherapy was 5.5 months.

Adverse events included cytopenias, gastrointestinal events, and infections in both arms (ASH 2019 Abstract 565).

There are also data to suggest benefits of the isocitrate dehydrogenase inhibitors ivosidenib in patients with HMA-refractory MDS with IDH1 mutations and enasidenib in patients with HMA-refractory MDS with IDH2 mutations, Dr. Jonas said.

Finally, he described a pilot and feasibility study of ex vivo screening of myeloid neoplasms for drug sensitivity conducted at Stanford (Calif.) University. In 21 patients with HMA-refractory MDS, the ex vivo screening system provided results in a clinically actionable time frame comparable to that of a 596-gene panel. The positive predictive value of the screen was 92%, the negative predictive value was 82%, and the accuracy was 85%.

“This looks like a potentially promising approach to offer personalized therapy in patients with MDS,” he said.

No funding source for the presentation was reported. Dr. Jonas disclosed consulting activities for AbbVie, Celgen, GlycoMimetics, Jazz, Takeda, Tolero, and Treadwell; institutional research funding from multiple companies; and discussion of off-label use of various drugs not specifically approved for MDS.

Several recently approved and late-phase investigational agents may improve care for patients with higher risk myelodysplastic syndrome (MDS) by augmenting hypomethylating agents (HMAs), which are the current standard of care.

“HMA failure remains a challenge, and new approaches, such as ex vivo drug screening, are needed to improve outcomes,” said Brian A. Jonas, MD, PhD, from the University of California, Davis, in an online presentation during the virtual American Society of Hematology (ASH) Meeting on Hematologic Malignancies.

The goal of treatment for patients with higher-risk MDS – defined as a Revised International Prognostic Scoring System (R-IPSS) intermediate, high-risk, or very high–risk category – is to alter as much as possible the natural history of the disease.

Treatment options include monotherapy with HMAs, HMAs in combination with other agents, high-intensity chemotherapy, allogeneic hematopoietic stem cell transplant (allo-HSCT), or a clinical trial, Dr. Jonas said.
 

Improving bioavailability

Although HMAs, either azacitidine or decitabine, remain the standard of care for patients with higher-risk MDS, the oral bioavailability of these agents is limited by the rapid clearance of cytidine deaminase in the gut and liver.

But as Savona and colleagues reported in The Lancet Haematology, the combination of oral decitabine with cedazuridine, a novel cytidine deaminase inhibitor, significantly improved the bioavailability of the HMA, with an efficacy comparable to that of intravenous decitabine. The findings were confirmed by results from the phase 2 ASCERTAIN trial.

The combination (Inqovi) was approved by the US Food and Drug Administration in July 2020 for the treatment of MDS and chronic myelomonocytic leukemia in IPSS intermediate-1 or higher risk categories. The approved dose is 35 mg decitabine and 100 mg cedazuridine in a single oral tablet once daily on days 1 through 5 of each 28-day cycle.
 

New drugs, potential new targets

Another promising approach to improving HMA therapy is the combination of azacitidine and the BCL-2 inhibitor venetoclax (Venclexta).

Results of a phase 1b study of the combination as first-line therapy for patients with higher-risk MDS showed a combined complete response and marrow complete response rate of 77.2%, with estimated 6-month and 12-month survival rates of 100% and 93.8%, respectively, for patients who had a complete response and 85.9% at both 6 and 12 months for patients with a marrow complete response.

“The question is does this challenge the standard of care for higher-risk MDS? I would argue that many are using the regimen since the abstract came out, and I myself consider this regimen for use in select patients with high–blast count MDS who are maybe going to transplant or need to have their disease controlled rapidly,” Dr. Jonas said.

A randomized trial of the combination (NCT04401748) is currently recruiting.
 

Novel checkpoint inhibitor

Another promising combination pairs azacitidine with magrolimab, an experimental immune checkpoint inhibitor that targets CD47, the “don’t eat me” signal that inhibits macrophages from carrying out their crucial phagocytosis role.

As previously reported, magrolimab in combination with rituximab showed good efficacy in patients with relapsed or refractory indolent or aggressive non-Hodgkin lymphomas, and more recently showed promise in combination with azacitidine in a phase 1b study for the treatment of MDS and acute myeloid leukemia (AML).

Among patients with MDS in the trial, the overall response rate was 91% (30 of 33 patients). In all, 14 patients had complete responses, one had a partial response, eight had marrow complete responses, and seven had hematologic improvement.

The tolerability profile was similar to that seen with azacitidine monotherapy, with no significant worsening of cytopenias or infections or autoimmune adverse events. There were no deaths in the first 60 days on therapy, and no treatment discontinuation for drug-related adverse events.

Azacitidine was paired with a different novel agent, APR-246 in a clinical trial testing the combination in patients with TP53 mutant MDS and AML. APR-246 is a novel, first-in-class small molecule that binds covalently to p53, and selectively induces apoptosis in metastatic TP53 cells via thermodynamically stabilizing the p53 protein and shifting equilibrium toward the wild-type conformation.

Among 33 evaluable patients with higher-risk MDS, the combination was associated with an overall response in 29 (81%) including 20 patients (61%) with a complete response. After a median follow-up of 10.8 months, the median duration of response was 7.3 months, and 17 patients went on to allo-HSCT.

The combination of magrolimab and azacitidine has also shown preliminary activity in TP53-mutated MDS, Dr. Jonas noted.
 

HMA-refractory disease

Patients who experience disease progression to AML or to higher-risk MDS; have stable disease but no complete, partial, or marrow responses; or have hematologic improvement after four to six cycles of HMA may have primary resistance to this class of agents. Patients can also have disease that develops resistance to HMAs after an initial response.

“Unfortunately, the prognosis is very dismal for these patients,” with a median overall survival of 5.6 months and 2-year overall survival of just 15%, Dr. Jonas said.

As reported at the 2019 ASH annual meeting, in patients with relapsed/refractory MDS, venetoclax plus azacitidine was associated with a median progression-free survival of 9.1 months versus 3.3 months for venetoclax alone, and a median overall survival for the combination that was not reached, with a 12-month overall survival estimate of 65%. The median overall survival with venetoclax monotherapy was 5.5 months.

Adverse events included cytopenias, gastrointestinal events, and infections in both arms (ASH 2019 Abstract 565).

There are also data to suggest benefits of the isocitrate dehydrogenase inhibitors ivosidenib in patients with HMA-refractory MDS with IDH1 mutations and enasidenib in patients with HMA-refractory MDS with IDH2 mutations, Dr. Jonas said.

Finally, he described a pilot and feasibility study of ex vivo screening of myeloid neoplasms for drug sensitivity conducted at Stanford (Calif.) University. In 21 patients with HMA-refractory MDS, the ex vivo screening system provided results in a clinically actionable time frame comparable to that of a 596-gene panel. The positive predictive value of the screen was 92%, the negative predictive value was 82%, and the accuracy was 85%.

“This looks like a potentially promising approach to offer personalized therapy in patients with MDS,” he said.

No funding source for the presentation was reported. Dr. Jonas disclosed consulting activities for AbbVie, Celgen, GlycoMimetics, Jazz, Takeda, Tolero, and Treadwell; institutional research funding from multiple companies; and discussion of off-label use of various drugs not specifically approved for MDS.